ANZBCTG Annual Report
Research for a world without breast cancer. Annual Report 1 April 2012 - 31 March 2013 1 April 2012 - 31 Mar ch 2013
The Australia and New Zealand Breast Cancer Trials Group is supported by its fundraising department the Breast Cancer Institute of Australia. Australia & New Zealand Breast Cancer Trials Group Email: [email protected] Web: www.anzbctg.org or scan the following QR code:
Trials Coordination Department Australia & New Zealand Breast Cancer Trials Group PO Box 155 Hunter Region Mail Centre NSW 2310 Australia Ph: (+61) 2 4985 0136 Fax: (+61) 2 4985 0141
Business Administration Department Australia & New Zealand Breast Cancer Trials Group PO Box 283 The Junction NSW 2291 Australia Ph: (+61) 2 4925 5255 Fax: (+61) 2 4925 3068
Fundraising & Education Department Breast Cancer Institute of Australia PO Box 283 The Junction NSW 2291 Australia Ph: (+61) 2 4925 3022 Fax: (+61) 2 4925 3068 Email: [email protected] Web: www.bcia.org.au
ANZ Breast Cancer Trials Group Limited ACN 051 369 496 ABN 64 051 369 496 ATO N0939
©2013. This report cannot be reproduced without the permission of the ANZ Breast Cancer Trials Group Ltd. All rights reserved. Contents
Contents 1
About Us 2
Chair’s Report 4
Chief Operating Officer’s Report 6
Research Report 8
Clinical Trials Open for Participant Entry 20
Clinical Trials Accrual Completed 30
Communication Report 36
Consumer Advisory Panel Report 38
Fundraising Report 40
Fundraising Results and Highlights 42
Governance 56
Contributors and Supporters 62
Financial Report 66
Publications 70
Glossary of Terms 72
ANZBCTG Annual Report 2012-2013 1 About Us
Our Mission: To eradicate all suffering from breast cancer through the highest quality clinical trials research. Our Vision: To be a global and regional leader in research collaboration committed to a world without breast cancer. Our Values: Excellent, Relevant, Transparent, Reputable, Inclusive, Innovative.
The Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) is the largest independent, oncology clinical trials research group in Australia and New Zealand. For more than 30 years, the ANZBCTG has conducted a national clinical trials research program for the treatment, prevention and cure of breast cancer.
The research program rigorously and scientifically tests the efficacy of new breast cancer treatments and prevention interventions through the conduct of multicentre national and international clinical trials. This program brings together over 600 researchers in 84 institutions throughout Australia and New Zealand.
Clinical trials are the essential tool to identify if a treatment or treatment strategy is safe, effective and has the potential to save lives. All new treatments or treatment strategies are rigorously tested through the clinical trials process before they are made widely available to the community.
The Breast Cancer Institute of Australia is the fundraising and education department of the ANZBCTG and was established in 1994 to increase awareness of, and seek ongoing funding for, the ANZBCTG research program.
Our aim is to eradicate all suffering from breast cancer and achieve the ultimate goal of “a world without breast cancer”.
2 ANZBCTG Annual Report 2012-2013 Dr Janine Lombard with Katy Keene who is a participant in the APHINITY clinical trial.
ANZBCTG Annual Report 2012-2013 3 Chair’s Report
Through collaboration, the ANZBCTG’s breast cancer clinical trials research program is making a real difference to the lives of women and their families.
In this my first report as Chair of the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG), I have reflected on the importance of patience and collaboration.
The international clinical trial ATLAS for example, was one of the first trials I was involved in with the ANZBCTG as a junior oncologist. Results for this trial were presented in December 2012 and showed that extending the use of tamoxifen from five years to 10 years reduces the risk of breast cancer recurrence and improves survival rates for women with oestrogen receptor (ER) positive breast cancer. The ANZBCTG coordinated the ATLAS study in Australia and New Zealand and 784 women participated in ATLAS across 32 institutions. This is a fantastic result that would not have been achieved without collaboration between academic researchers around the world, women participating in our trials and our members.
Today, one in eight women in Australia will be diagnosed with breast cancer by the age of 85 and on average, 37 Australian women will be diagnosed with breast cancer each day. While mortality rates for breast cancer are falling, thanks in large part to discoveries made by clinical trials research, breast cancer still remains the most common cancer in Australian women. They are sobering statistics and reinforce the importance of breast cancer clinical trial research in both prevention and treatment.
Significant highlights in the reporting period include:
• The number of women who have participated in ANZBCTG clinical trials from Australia and New Zealand now exceeds 14,000; • The enrolment of women to five clinical trials and two trial substudies; • An excellent contribution from participating institutions to a high profile international trial APHINITY, which is evaluating the efficacy and safety of a new drug, called pertuzumab, in the treatment of patients with HER2-positive breast cancer. 98 women were enrolled during the reporting period from 15 institutions in Australia and New Zealand; • Strong financial results with a net income of $2.603 million, which enables the ANZBCTG to undertake its research program; • Excellent results from our fundraising department, the Breast Cancer Institute of Australia.
4 ANZBCTG Annual Report 2012-2013 Governance
The ANZBCTG is governed by a Board of Directors, which is comprised of six elected Directors and three appointed Directors. I would like to thank my predecessor Associate Professor Jacquie Chirgwin, whose term as Chair was completed in July 2012. Under Jacquie’s leadership our Board was restructured to include appointed members with financial expertise, the ANZBCTG’s financial position was strengthened and our membership continued to grow throughout Australia and New Zealand. On behalf of the Board of Directors, I thank Jacquie for her leadership, commitment and ongoing support. She has left a larger and more complex garden to tend.
We welcomed Associate Professor Prue Francis to the role of Vice Chair of the ANZBCTG’s Scientific Advisory Committee (SAC) in November 2012. Prue joins SAC Chair, Associate Professor Nicholas Wilcken, as SAC’s leadership team. Meanwhile, Jennifer Bryce retired from the ANZBCTG’s Consumer Advisory Panel (CAP) at the end of 2012, after almost 10 years as a CAP member and we thank Jenny for her invaluable contribution. We welcome new CAP members Petrina Burnett and Leslie Gilham, who both bring extensive consumer advocacy experience to their roles. Strategic Planning
Clinical trials are facing a number of challenges in the future, as they become more complex and multidisciplinary, and it is important that the ANZBCTG is in a position to be able to meet those challenges. The Strategic Planning Framework has determined our operational goals between 2009-2014 and focuses on delivering high quality clinical trials based on excellent science; translation of research results; adequate resourcing and sustainability of our research program; and opportunities to engage with ANZBCTG members, collaborators and other key stakeholders. The Board of Directors, ANZBCTG Committee representatives and senior ANZBCTG staff will meet later this year to start developing our next strategic plan. Summary
This is a very exciting time for breast cancer clinical trials research. We are in the era of molecular biology and as a result, this will enhance the treatments available to patients with specific targeted therapies. We hope to be able to develop a platform for molecular testing of secondary breast cancer samples in order to tailor trials to women who need new therapies.
I would like to thank all ANZBCTG members and researchers, and women who participate in our clinical trials, for their contribution to our research program. I would also like to acknowledge the fantastic results from our fundraising and education department, the Breast Cancer Institute of Australia, and thank our donors and corporate supporters, particularly Avon and the Commonwealth Bank.
It is through these collaborations that the ANZBCTG’s clinical trials research program is making a real difference to the lives of women and their families.
Professor Frances Boyle AM Chair, Board of Directors
ANZBCTG Annual Report 2012-2013 5 Chief Operating Officer’s Report
The foundations have been laid for us to develop our next five year strategic plan and we can be confident that the ANZBCTG is in a position to take advantage of future research opportunities.
It is a pleasure to work with an organisation that is dedicated to such a worthy goal - “a world without breast cancer”. The commitment to excellence and the highest quality clinical trials research is an inspiration, and is demonstrated by everyone involved in the conduct of the ANZBCTG’s research program.
With responsibility to manage the ANZBCTG’s overall business performance, I am supported by a hardworking and dedicated team and I am pleased to report that the ANZBCTG has had an excellent year. Together we have worked to improve efficiencies within the Group, simplify processes and update governance procedures to maintain compliance. Operations
The Australian Government launched the Australian Charities and Not for Profits Commission (ACNC) in 2012. Its aim is to maintain, enhance and build public trust in the not for profit sector through increased accountability and transparency and with a further aim to streamline reporting procedures. The ANZBCTG reviewed its operations to ensure compliance with the new regulations the ACNC has introduced and those they plan to systematically introduce in the coming years.
During the reporting period, the ANZBCTG conducted its biennial review of policies and procedures, which provide clarity and guidance for the organisation and staff about roles, responsibilities and obligations. The Group has worked to ensure our policies are focused, legally correct and reviewed by all staff. Procedures have been separated from policies for clarity and relate to specific roles within the Group. The review also provided the opportunity to simplify the process for future years.
An eCRF system of data collection is a more efficient way of managing, checking and evaluating clinical trial data. We have spent time reviewing current commercial systems and their associated costs, resources and support. Discussions with one of our collaborative partners in Europe, the Breast International Group (BIG), provided further information on their experience with this technology. We are currently reviewing options for an eCRF system with the intent of introducing it in the near future.
Dr Nicholas Zdenkowski joined the ANZBCTG in early 2013 as the Group’s Clinical Fellow. This position aims to provide young clinical researchers with educational, research and career development opportunities through their engagement with the ANZBCTG and its research program. Nick works as a medical liaison to assist with
6 ANZBCTG Annual Report 2012-2013 auditing and medical review of data, clinical queries from study institutions and communication with study investigators. He also assists with the medical aspects of trial development through to data analysis and manuscript preparation for publication.
The ANZBCTG has recently introduced a program to acknowledge length of service and to thank staff for their invaluable contribution to the Group. We have approximately 60 staff across our three departments of Business Administration, Trial Coordination and Fundraising. I sincerely thank all staff for their tireless efforts. Special certificates were presented in three categories based on length of service:
Fifteen Years (Plus) - Julie Callaghan, Dianne Lindsay and Lisa Paksec.
Ten Years (Plus) - Heath Badger, Akiko Fong, Jenny Leggett, Kelly Martin, Alison Newton and Rochelle Thornton.
Five Years (Plus) - Lauren Boyes, Annette Dempsey, Donna Douglass, Nicole Francis, Sharyn Frank, Leigh Hainsworth, Belinda Mitchell, Rebecca Moder, Anthony Morrison, Katie Oleksyn, Flonda Probert, Kristy Schmidt, Christine Wasik, Coralie Watson and Stacey Wilks. Financial Position
The ANZBCTG is in an excellent financial position thanks to careful allocation of resources, prudent financial management and the commitment of our supporters. It is vitally important that we are in a position to be able to plan, develop, conduct and complete clinical trials that improve the treatment and prevention strategies available to women. We have an emphasis on strong financial management so that we are able to fund trials that may take several years to complete and to start new trials that are relevant and will benefit the community. David Pringle, our Financial Controller, has spent time reviewing our accounts system, working with the three departments to develop a five year forecast budget to complement our strategic plan.
The BCIA has had a successful year and I thank our many individual and corporate supporters for their continued support. The ANZBCTG holds grants from the Breast Cancer Research Foundation (USA), National Health and Medical Research Council, Cancer Australia and the National Breast Cancer Foundation.
For more information on the Group’s financial position please refer to page 66. Summary
The ANZBCTG is committed to the highest quality clinical trials research to identify treatments that are safe, effective and have the potential to save lives. The foundations have been laid for us to develop our next five year strategic plan and we can be confident that the ANZBCTG is in a position to take advantage of future research opportunities.
The collaboration between our members, staff, donors, supporters and women who participate in the ANZBCTG’s research program, ensures that improvements will continue to be made for women at risk of breast cancer or who have been diagnosed with breast cancer.
Dr Soozy J Smith Chief Operating Officer
ANZBCTG Annual Report 2012-2013 7 Research Report
The Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) is the largest independent, oncology clinical trials research group in Australia and New Zealand. It conducts clinical trials for the treatment and prevention of breast cancer. Breast cancer research conducted in Australia, predominantly by the ANZBCTG, has contributed to the significant improvement in breast cancer related mortality that has occurred over the last 20 years.
Significant research achievements during the reporting period include:
• Completion of the recruitment phase of the IBCSG 35-07 SOLE and IBCSG 22-00 trials; • Analysis and publication of longer term data from the ATLAS trial (summarised on page 11); • Contribution to the St Gallen 2013 International Breast Cancer Consensus Panel. A paper is in preparation; • The final analysis of the neoadjuvant trial ANZ 0501 NeoGem has been completed and a paper prepared.
Mortality rates for breast cancer continue to fall, largely as a result of the application of treatments shown to be beneficial by clinical trials and is a triumph for clinical trials research. The consequence is that the prospects for breast cancer control are better now than at any previous time. The ANZBCTG continues to make remarkable progress through national and international collaboration.
This collaboration facilitates the conduct of clinical research in 84 institutions throughout Australia and New Zealand and ensures the efficient sharing of knowledge, expertise and resources. As a result of this teamwork the translation of research into improved patient outcomes is greatly enhanced. Collaborative group clinical trials research, led by academic clinicians, is unique in its focus on answering the clinically important questions that translate into such improved outcomes for women.
Since the Group’s inception in 1978 the ANZBCTG has been involved in many of the most important practice changing breast cancer trials. This research has provided more treatment options for women throughout the world who are diagnosed with breast cancer and encompasses the broad spectrum of breast cancer research, from the prevention of the disease in women at high risk of breast cancer, through to the treatment of metastatic breast cancer.
8 ANZBCTG Annual Report 2012-2013 The results of key trials coordinated in Australia and New Zealand by the ANZBCTG are outlined below: ANZ 8101
In 1987 a seminal paper was published in the New England Journal of Medicine reporting the results of the ANZ 8101 randomised clinical trial which tested strategies of continuous versus intermittent chemotherapy for metastatic breast cancer in 308 women. The trial results improved our understanding of the optimal management of advanced disease showing not only superior tumour control with continuous chemotherapy but also better quality of life. International Breast cancer Intervention Study – IBIS-I
In 2002 it was shown that, in pre and postmenopausal women at increased risk of breast cancer, tamoxifen reduced the risk of developing hormone-sensitive breast cancer by about one third. These benefits continued for at least another five years after treatment had stopped. In 2006, longer term results confirmed the initial findings. The results were an important step towards the provision of effective prevention strategies for all women at risk of breast cancer and also provided a sound scientific basis for the IBIS-II trial. IBCSG 15-95
This study evaluated the role of a dose-intense regimen of epirubicin and cyclophosphamide every two weeks, with growth factor and stem cell support, compared to a standard-dose, anthracycline-based chemotherapy regimen, in the adjuvant treatment of high risk breast cancer. The results were first presented in 2003, and published in the Journal of Clinical Oncology in 2006. Internationally, 344 women were randomised and after 5.8 years, there was a trend towards improved overall survival and disease-free survival in the dose-intense regimen. A retrospective analysis suggested that women under 40 years of age received benefit from the dose-intense regimen. At 8.3 years follow-up, a disease-free survival benefit was seen in women with oestrogen receptor-positive breast cancer, which may relate to the endocrine effects of chemotherapy rather than the chemotherapy itself. This study is one of a small number of studies that compared immediate multiple cycle, dose-intense chemotherapy to standard-dose chemotherapy regimens. The overall results contributed to a shift away from dose-intense chemotherapy regimens requiring growth factor and stem cell support. BIG 02-98 / IBCSG 20-98
In this study the activity of the taxane drug, docetaxel, given either in combination or after treatment with doxorubicin, followed by the combination of cyclophosphamide, methotrexate and 5-fluorouracil (CMF) was evaluated in node-positive breast cancer. The two methods of docetaxel administration were compared with doxorubicin alone or in combination with cyclophosphamide, followed by CMF. The results were first presented in 2006 and published in the Journal of the National Cancer Institute in 2008. This study was a major achievement for the ANZBCTG with accrual of 605 women from Australia and New Zealand and of a total international accrual of 2,887. All treatment groups fared better than expected, irrespective of the chemotherapy regimen received – evidence that careful application of standard therapy in the clinical trial context can lead to optimal outcomes for participants. In October 2006, the Pharmaceutical Benefits Scheme (PBS) in Australia began to reimburse docetaxel chemotherapy for node-positive breast cancer. ANZ 0101 / BIG 01-01 HERA
The HERA trial is an example of how a large, high quality international collaborative trial can change clinical practice. HERA showed that adjuvant trastuzumab reduces the risk of death for women with HER2-positive early breast cancer, leading to the registration and PBS funding of this therapy in October 2006 for Australian women with HER2-positive early breast cancer. The ANZBCTG contributed to negotiations with government, policy and advocacy organisations which facilitated this process. These results led to other new international trials for HER2-positive early breast cancer, including the global ANZ 0702 / BIG 2-06 ALTTO and ANZ 1102 / BIG 4-11 APHINITY trials which are now in process.
ANZBCTG Annual Report 2012-2013 9 ANZ 9801 ATAC
The ATAC (Arimidex® (anastrozole), Tamoxifen, Alone or in Combination) study was pivotal in establishing aromatase inhibitors (AIs), in particular anastrozole, as an adjuvant endocrine therapy option for postmenopausal women with hormone receptor-positive early breast cancer. The standard of care prior to ATAC was the use of tamoxifen in both pre and postmenopausal women with hormone receptor-positive early breast cancer. Women who participated in the ATAC study and who received anastrozole for five years after surgery had a 24% lower risk of cancer recurrence than women who received five years of tamoxifen. These results led to the registration of anastrozole for the treatment of early breast cancer in many countries.
Later analyses provided evidence of a larger carryover effect after five years of adjuvant treatment with anastrozole compared with tamoxifen. Based on these results the St Gallen 2003 International Breast Cancer Consensus Panel included the option of giving anastrozole to postmenopausal women in the adjuvant breast cancer setting “if tamoxifen is contraindicated” in their recommendations. A similar statement was published in the Journal of Clinical Oncology (Winer et al. 2005;23(2):619-629) American Society of Clinical Oncology (ASCO) Technology Assessment update when the panel recommended that adjuvant hormonal therapy for postmenopausal women with hormone receptor-positive breast cancer should “include an AI as initial therapy or after treatment or sequential therapy consisting of tamoxifen (for two to three years or five years) followed by AIs for two to three years or five years”. Intergroup Exemestane Study (IES)
A successful new treatment approach for early breast cancer, using tamoxifen therapy first and then switching to the aromatase inhibitor drug exemestane in sequence, instead of the standard continuous tamoxifen, was reported in The New England Journal of Medicine in 2004. The analysis found that switching to exemestane therapy for two to three years after the initial two to three years of tamoxifen resulted in a significant improvement in both disease-free survival and a significant reduction of new breast cancers in the contralateral breast, when compared with five years of continuous tamoxifen treatment. Longer term data, reported in 2009 after 91 months of follow-up, also demonstrated a significant survival benefit for women who were switched to exemestane compared to those who remained on tamoxifen. BIG 01-98 / IBCSG 18-98
In 2005 the BIG 01-98 trial, which included the largest number of women recruited to an international breast cancer treatment trial from Australia and New Zealand, showed that letrozole for five years was superior to tamoxifen for five years in preventing breast cancer recurrence, especially distant recurrence. A 2009 update was published in the New England Journal of Medicine, showing a continued significant reduction (12%) in recurrences (including second malignancies and deaths prior to cancer event), and evidence of a reduction (13%) in deaths. As a result of ATAC, IES and BIG 01-98, aromatase inhibitors have become part of the standard treatment for postmenopausal women with hormone receptor-positive early breast cancer. ANZ 0001
Led by the ANZBCTG, this study compared oral capecitabine with standard chemotherapy (cyclophosphamide, methotrexate, 5-fluorouracil) as first-line chemotherapy in women with advanced breast cancer unsuited to more intensive regimens, and was published in 2011 in the Journal of Clinical Oncology. Women receiving capecitabine had superior overall survival, with a favourable side effect profile allowing longer duration of treatment. These results increased the confidence with which clinicians and patients might choose a relatively low impact chemotherapy regimen, without compromising outcomes.
The contribution of ANZBCTG research to international consensus statements, treatment guidelines, meta-analyses and overviews, including in the breast cancer sphere, the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) or ‘Oxford Overview’, St Gallen International Breast Cancer Consensus Panel statements and Cochrane reviews, continues to optimise the translation of breast cancer research into better health and wellbeing for women diagnosed with breast cancer.
10 ANZBCTG Annual Report 2012-2013 Publications
The past year has seen a number of important achievements in breast cancer control. The results underline the value of careful, scientifically based clinical research. Our Group has made a substantial contribution to several of these achievements. In this reporting period, the ANZBCTG contributed to 21 papers published in peer- reviewed journals. A full list of these publications is available on pages 70 to 71. Eight of these publications are summarised below:
The protective effect of tamoxifen persists to at least 15 years.
The Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) clinical trial was published in The Lancet in March 2013 and presented at the San Antonio Breast Cancer Symposium, USA in December 2012. The results show that gains can still be made using an established, affordable drug such as tamoxifen.
The Early Breast Cancer Trialists’ Collaborative Group meta-analysis showed that five years of adjuvant tamoxifen reduces the risk of breast cancer recurrence and death, and that the protective effect persists for 15 years after diagnosis. The ATLAS investigators randomly assigned 6,846 women who had completed five years of tamoxifen as adjuvant treatment for hormone-sensitive breast cancer to stop tamoxifen or to continue for another five years. Most participants were postmenopausal, and half had positive lymph nodes at initial surgery.
No significant difference was seen at the end of the treatment period, but after a further five years of follow-up (10-14 years after diagnosis), the group who continued on tamoxifen for a total of 10 years had fewer breast cancer recurrences, breast cancer deaths, and deaths from any cause. There were 83 fewer deaths and 94 fewer breast cancer recurrences in the extended treatment group. This equates to recurrence rates between years 5-14 of 21.4% for women who continued to 10 years, compared with 25.1% for women who were asked to stop tamoxifen at five years, and mortality of 12.2% versus 15.0% respectively. Of the women allocated to continue tamoxifen who had not experienced a recurrence, 84% were still taking tamoxifen two years after study entry (seven years after diagnosis).
The benefits of continuing tamoxifen therapy far outweighed the risks between 5-14 years after a breast cancer diagnosis. The risks included slightly increased rates of pulmonary embolus (blood clot in the lung/blockage of a lung artery), with 0.5% higher incidence, and endometrial cancer, 0.2% higher mortality, which are known side effects of tamoxifen therapy. The risk of ischaemic heart disease was lower in the extended tamoxifen group.
These data confirm that a longer duration of endocrine therapy reduces rates of recurrence and mortality, and raise the question of whether tamoxifen should be taken for longer than 10 years. The results cannot be extrapolated to extended duration of adjuvant aromatase inhibitor therapy, or to extended switch strategies. It is important that researchers continue to follow these patients due to the risk of late recurrence in women who have had hormone-sensitive breast cancer. The researchers considered these results to be preliminary and further analyses will be undertaken. The results will also be combined with a meta-analysis of all the international tamoxifen duration clinical trials.
This article was published in The Lancet in March 2013 (381(9869):805-816), please refer to page 71.
ANZBCTG Annual Report 2012-2013 11 Cognitive change during breast cancer therapy.
Cognitive change, or problems with memory and thinking, is a significant concern for women receiving chemotherapy and/or endocrine (hormone or ‘anti-oestrogen’) therapy following a breast cancer diagnosis. A previous data analysis from the BIG 01-98 clinical trial showed an improvement in measured cognitive function after adjuvant endocrine therapy had been completed.
This substudy, of 100 women who took part in the BIG 01-98 trial, used self-completed questionnaires to measure the degree of subjective cognitive impairment reported by women at the end of five years of endocrine therapy for early breast cancer, and again one year later. Subjective cognitive impairment was assessed using the Cognitive Failures Questionnaire, a 25-item measure of memory, perception, attention and motor function over the preceding six months. Psychological distress was measured using the 12-item General Health Questionnaire.
Between year five and year six, the only significant differences found in subjective cognitive function or any other problems reported by women, was a significant decrease in hot flushes. A decrease in hot flushes is expected after endocrine therapy is completed. Items that were considered particularly bothersome by women who reported the highest level of subjective cognitive impairment included forgetting people’s names, inability to remember something, forgetting the location of items and forgetting the reason for going from one part of the house to another. These problems did not improve after endocrine treatment stopped.
The findings from research using measures of objective and subjective cognitive impairment after completion of adjuvant endocrine therapy are contradictory. Subjective cognitive impairment is not well defined and is difficult to measure. It is possible that questionnaires designed to measure cognitive function objectively are not asking the right questions. This study is the first to investigate changes in subjective cognitive function after completion of adjuvant endocrine therapy. Considering the substantial numbers of women this relates to, further research is needed to evaluate the reason for the difference between what the tests show, and what women feel about their cognition.
This paper was published in the British Journal of Cancer in May 2012 (106(10):1618-1625), please refer to page 71.
Immunohistochemistry score to predict distant recurrences in premenopausal patients with endocrine-responsive breast cancer.
There are a range of tools available to estimate an individual woman’s risk of recurrence and death from early breast cancer. Their use in clinical practice is limited by availability and cost (e.g. OncotypeDX®), and by limited applicability in particular subgroups (e.g. Adjuvant! Online in HER2-positive disease). The risk of breast cancer recurrence and mortality are discussed by clinicians with their patients when deciding whether treatment should include adjuvant endocrine therapy or chemotherapy, or both treatments. An immunohistochemical recurrence score could be reported by most pathology laboratories, so has the potential to help make this decision without a substantial increase in cost or processing time.
IBCSG VIII is an international multicentre clinical trial for pre and perimenopausal women with node-negative breast cancer who were randomised to receive goserelin (a suppressor of oestrogen production in premenopausal women) for 24 months, a classical chemotherapy regimen of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) for six months, or CMF for six months followed by goserelin for 18 months. At a median of 12 years follow-up, of those with oestrogen receptor (ER) positive tumours, the women who received CMF followed by goserelin had improved disease-free survival compared to women who received CMF or endocrine therapy alone.
This paper describes the development of a score which assesses tumour size, presence of peritumoural vascular invasion, ER-positivity, and Ki-67, to predict for distant recurrence. This recurrence score model was found to be significantly better than Adjuvant! Online at predicting distant recurrence within five years of surgery. Women with a high recurrence score benefited from CMF, whereas those with a low recurrence score had equivalent distant recurrence-free survival whether they received chemotherapy or not.
This research showed that an immunohistochemical score can identify pre or perimenopausal women with
12 ANZBCTG Annual Report 2012-2013 endocrine-responsive, node-negative breast cancer, who are at a low risk of distant recurrence within five years. Scores such as this can be used to determine which women should receive chemotherapy and which women can safely avoid it.
This paper was published in The Breast in October 2012 (21(5):621-628), please refer to page 70.
The significance of the TP53 gene mutation in breast cancer.
The TP53 gene provides instructions for making a protein called tumour protein p53. This protein stops cells from growing or dividing too fast or in an uncontrolled way. Mutations in the TP53 gene are associated with larger tumours and more advanced disease than breast cancers without TP53 mutations. This analysis, conducted by ANZBCTG researchers including Professor Alan Coates and the late Professor Robert Sutherland, evaluated the relationship between p53 expression and the oestrogen receptor status of tumour samples collected from women who participated in IBCSG trials VIII and IX. Trial VIII assigned premenopausal women to either endocrine therapy with goserelin, or cyclophosphamide, methotrexate and 5-fluorouracil (CMF) alone, or CMF followed by goserelin. Trial IX assigned postmenopausal women to tamoxifen alone or CMF followed by tamoxifen. Tumour samples from 1,493 women were sent from the International Breast Cancer Study Group Pathology Office in Milan Italy, to the Garvan Institute in Sydney Australia, for analysis using tissue microarrays.
Mutations in the TP53 gene were more likely to be found in oestrogen receptor (ER) negative, triple-negative (ER, PgR and HER2, all negative), and HER2-positive breast cancers. It was shown that the presence of TP53 mutation in ER-positive tumours was associated with worse disease-free survival (DFS) and overall survival (OS). On the other hand, the presence of TP53 mutation in ER-negative tumours was associated with better DFS and OS. Mutation of TP53 was associated with better outcomes for women with triple-negative and HER2-positive tumours. CMF chemotherapy and endocrine therapy were equally effective, whether a TP53 mutation was present or not. This study exemplifies the complex interdependence of biological markers in breast cancer. It may explain previously disparate reports of the prognostic relevance of the TP53 mutation in breast cancer. The authors concluded that interpretation of the prognostic significance of p53 staining requires consideration of the ER status of the tumour.
This paper was published in Breast Cancer Research in November 2012 (14(6):R143), please refer to page 70.
Patterns and risk factors for locoregional failures after mastectomy for breast cancer.
Radiotherapy after mastectomy for breast cancer may be offered to women with certain risk factors for recurrence. The aim of this analysis of 13 International Breast Cancer Study Group (IBCSG) clinical trials was to identify women who would benefit from radiotherapy after mastectomy, and conversely, those who may be able to safely avoid radiotherapy treatment.
This research assessed the number and type of local recurrences reported in 8,106 women who had been treated with breast surgery and axillary dissection followed by chemotherapy and/or endocrine therapy, who did not receive radiotherapy, with a median follow-up of 15.2 years. The number of recurrences to the chest wall, axilla and supraclavicular fossa, were analysed by patient age, the number of nodes removed and the number of nodes found to be positive. The results support post-mastectomy radiotherapy to the chest wall and supraclavicular fossa in women with four or more positive nodes, due to high rates of local recurrence in this group. The authors also recommend consideration of chest wall radiotherapy in patients with one to three positive nodes who have one of the following risk factors: age less than 40 years; or if fewer than seven uninvolved nodes were removed; or peritumoural vascular invasion was identified. The rate of axillary recurrence was low in all patient groups, supporting omission of radiotherapy to the dissected axilla.
There is emerging evidence that due to the effectiveness of current endocrine therapy and chemotherapy treatment regimens, carefully selected patients can safely receive less axillary treatment, including axillary dissection surgery and radiotherapy to the axillary region. The authors concluded that further research should be undertaken in this area.
ANZBCTG Annual Report 2012-2013 13 The ANZBCTG is leading the ANZ 1002 PROSPECT clinical trial, which is investigating whether magnetic resonance imaging (MRI) of the breast can be used to identify women who can safely avoid radiotherapy to the breast after breast conserving surgery, due to a low risk of recurrence (please refer to page 27 in the Clinical Trials Open for Participant Entry section).
This paper was published in the Annals of Oncology in November 2012 (23(11):2852-2858), please refer to page 70.
Obesity and breast cancer recurrence.
Women who are obese are at an increased risk of breast cancer recurrence and mortality after a diagnosis of early breast cancer. The BIG 01-98 clinical trial randomly assigned 4,922 postmenopausal women with early breast cancer to five years of either tamoxifen or letrozole and a further 3,106 postmenopausal women to both drugs in sequence for a total of five years. Letrozole was shown to be superior to tamoxifen in the overall analysis. This analysis of BIG 01-98 looked at whether breast cancer recurrence and mortality differed in women whose weight was in the normal, overweight or obese range.
Previous trials have suggested that aromatase inhibitors supress oestrogen less effectively in obese women, due to an excess of the aromatase enzyme in adipose (fat) tissue. Incomplete suppression of oestrogen production may limit the benefit of adjuvant hormonal therapy in women with hormone receptor-positive early breast cancer. In this trial, obese women (Body Mass Index (BMI)>30 kg/m2) had a slightly poorer overall survival than women with a normal BMI (<25 kg/m2). No difference was seen in women who were overweight (BMI 25-29 kg/m2). Letrozole was more effective than tamoxifen in all BMI categories.
These results indicate that letrozole is an effective treatment option for obese individuals. This survival effect in obese women was not seen in a similar analysis of the ATAC trial, which suggested that anastrozole may be less effective in obese women. Caution is advised, however, as this is not a direct comparison between letrozole and anastrozole. Other research has shown that overweight or obese women should still be advised to lose weight as an important part of their breast cancer treatment strategy.
This paper was published in the Journal of Clinical Oncology in November 2012 (30(32):3967-3975), please refer to page 70.
Prognostic and predictive value of tumour infiltrating lymphocytes in lymph node-positive breast cancer.
BIG 02-98, described on page 9, compared anthracycline and anthracycline-taxane chemotherapy regimens for women with node-positive early breast cancer. This analysis investigated whether the presence of a tumour immune response was prognostic and predictive of benefit from anthracycline chemotherapy, which is believed to stimulate an immune system response. Tumour infiltrating lymphocytes (TILs) were more likely to be present with infiltrating ductal carcinoma histology, high histologic grade, hormone receptor-negativity and high Ki-67 expression. TILs have previously been shown to correlate with good prognosis and higher response rates to neoadjuvant chemotherapy for early breast cancer. In the whole trial population, there was no correlation between TILs and prognosis. In a subgroup analysis, increased lymphocytic infiltrate correlated with substantially reduced rates of recurrence and mortality in patients with ER-negative, HER2-negative tumours. In terms of chemotherapy response, the only significant difference was in disease-free survival in women with HER2-positive breast cancers. Within this group, the presence of TILs predicted for better disease-free survival in those treated with anthracycline based therapy, but not for those treated with anthracycline and taxane.
These data show that TILs are prognostic in ER-negative, HER2-negative breast cancer, and suggest that immune mechanisms may be a worthwhile target to investigate in triple-negative breast cancer, which by definition lacks a target for treatment. Anti-HER2 therapy was not used for women with HER2-positve breast cancer in this study, and it is unclear what the interaction might be between the immune system and therapies such as trastuzumab.
This paper was published in the Journal of Clinical Oncology in March 2013 (31(7):860-867), please refer to page 71.
14 ANZBCTG Annual Report 2012-2013 HERA: Risk of central nervous system relapse with or without one year of adjuvant trastuzumab.
ANZ 0101 / BIG 01-01 HERA randomised women with HER2-positive early breast cancer who had received standard neoadjuvant or adjuvant chemotherapy to either observation, one or two years of treatment with trastuzumab. A disease-free survival benefit was shown with trastuzumab, however 52% of patients in the observation arm crossed over to receive trastuzumab, obscuring any survival benefit that may have been seen. This analysis was undertaken to determine whether adjuvant trastuzumab affects the pattern of breast cancer recurrence in the central nervous system (CNS).
It is known that as trastuzumab does not cross the intact blood-brain barrier, hence relapse in the CNS may be more likely to occur after adjuvant treatment with trastuzumab. Incidence of CNS relapse as the first or subsequent site of relapse was estimated from the 3,401 patients assigned to observation or one year of trastuzumab. Two percent of patients in both groups had a CNS relapse as their first disease-free survival event, at a median of 1.2 years follow-up. Non-CNS relapses were significantly reduced by trastuzumab. Of the patients who had died, and where data was available, CNS disease was present in 47% of the trastuzumab group, and 57% of the observation group, a non-significant difference.
Encouragingly, women in this trial had a low rate of CNS recurrence as their first recurrence event. The rate was the same whether they received trastuzumab or not, suggesting that trastuzumab does not increase the chance of CNS recurrence. These results will be combined into a meta-analysis of individual patient data to better estimate whether there is a difference in the rate of CNS metastases after adjuvant trastuzumab.
This article was published in the Lancet Oncology in March 2013 (14(3):244-248), please refer to page 71.
ANZBCTG Annual Report 2012-2013 15 Annual Scientific Meeting
We were pleased to welcome an outstanding faculty to our Annual Scientific Meeting (ASM) in July 2012 in Hobart, Tasmania. More than 170 ANZBCTG members and international guest speakers participated in an exceptional scientific program, which brought together experts to present the latest research and developments in breast cancer control. The ASM helps to establish links with other international breast cancer trials groups and has led to valuable new collaborations.
International speakers at the 2012 ASM – Professor Nancy Davidson, Professor Jack Cuzick, Professor Allison Kurian, Dr William Wood, Dr Lina Pugliano, Professor Alastair Thompson and Associate Professor Stacey Moulder.
The ANZBCTG established the John Collins Fellow Medal and Travel Grant to encourage breast cancer surgeons and registrars to become involved in clinical trials research. The award enables an early career surgeon or registrar the opportunity to attend the ASM, to learn about current breast cancer clinical trials and network with experienced breast cancer clinicians and trialists. The award is named after one of the founding members of the ANZBCTG, former member of the ANZBCTG Board of Directors and the Scientific Advisory Committee, Professor John Collins. The 2012 recipient was Dr April Wong.
The ASM scientific sessions provided important access for our members to international and national speakers, including:
• Professor Jack Cuzick Wolfson Institute of Preventative Medicine, UK; Dr April Wong receives the John Collins • Professor Nancy Davidson Medal at the 2012 ASM. University of Pittsburgh Cancer Institute & UPMC Cancer Centers, USA; • Professor Allison Kurian Stanford University School of Medicine, USA; • Associate Professor Stacy Moulder The University of Texas MD Anderson Cancer Center, USA; • Dr Lina Pugliano Breast International Group (BIG), Belgium; • Professor Alastair Thompson University of Dundee, Scotland; and • Dr William Wood Emory University School of Medicine, USA.
16 ANZBCTG Annual Report 2012-2013 ASM Awards and Travel Grants
The ANZBCTG provides assistance through Travel Grants and a Study Coordinator Prize to enable members to attend the ASM. Travel Grants are available to study coordinators, junior clinicians or other Group Members who are unable to access institutional or other funding. This year, 16 travel grants were awarded to delegates from Australia and New Zealand. The Study Coordinator Prize is awarded annually by the Board of Directors.
These initiatives are sponsored by Avon and aim to provide an opportunity for new breast cancer researchers to advance their knowledge.
Travel Grant recipients for the 2012 ASM were:
• Ms Ann Baker, Newcastle Private Hospital, NSW; • Mrs Francesca Berger, Austin Health, VIC; • Dr Ian Collins, Peter MacCallum Cancer Centre, VIC; • Dr Katharine Cuff, The Princess Alexandra Hospital, QLD; • Miss Giuliana D’Aulerio, Western Australian Institute of Medical Research, WA; • Ms Isabel Davis, Southern Highlands Cancer Centre, NSW; • Ms Amber Degelia, St Vincent’s Hospital, Melbourne, VIC; • Miss Cassie Freriechs, The Tweed Hospital, QLD; • Dr Sally Greenberg, Western Health, VIC; • Ms Anne Liggins, Waikato Hospital, New Zealand; • Ms Megan Livingston, Calvary Mater Newcastle, NSW; • Dr Christopher Pene, St Vincent’s Hospital, Sydney, NSW; • Miss Danielle Rapson, South Eastern Private Hospital, VIC; • Ms Jenni Scarlet, Waikato Hospital, New Zealand; • Ms Amy Tang, Box Hill Hospital, VIC; and • Dr Anuradha (Anna) Vasista, Westmead Cancer Care Centre, NSW.
ANZBCTG Study Coordinator Prize acknowledges the outstanding commitment by a study coordinator to breast cancer clinical trials research and was presented to Ms Sue Davoren from the Royal Hobart Hospital during the Trials Coordination Forum at the ASM.
Sue Davoren is presented with the Study Coordinator Prize at the 2012 ASM by the Head of Trials Management Dianne Lindsay.
ANZBCTG Annual Report 2012-2013 17 Operations
New approaches are needed for trial design, for patient selection and to improve the development and management of clinical trials from concept to analysis. The face of breast cancer research is changing: new molecular knowledge and translational research must be incorporated in clinical trial design. We can expect to see more clinical trials targeted to niche patient populations initiated and completed over shorter time periods. Planning, development, implementation, conduct and analysis of clinical trials across multiple institutions nationally and internationally, is a complex logistical exercise, which is continually reviewed and improved. Our aim is to be strategic, to target specific areas of research across all the disciplines involved in breast cancer research to ensure we are equipped to meet the challenges of the next generation of trials.
The time required to obtain approval to set up and to start enrolling participants to new clinical trials at hospitals worldwide was reported recently in a paper published in The Oncologist (Metzger-Filho et al. 2013;18(2):134-140), refer to page 71. Time to regulatory approval, time to ethics approval and time to the entry of the first and last participant for the ALTTO study, which opened in 44 countries, was measured across geographical regions. The average time from ethics approval to the entry of the first patient was 169 days, highlighting the long time intervals required to activate a global phase III clinical trial. While the results cannot be generalised this paper raised awareness within the research community that improvements can be made to the trial activation processes.
The ANZBCTG is working with other international groups to ensure more effective and efficient trial conduct. We will also continue to provide opportunities for our members to apply for Discretionary Research Funding to support the development of new research concepts. All research proposals must have prior ANZBCTG Scientific Advisory Committee (SAC) approval and be either related to existing research studies or relevant to the overall research agenda of the ANZBCTG.
During the reporting period we were pleased to approve the participation of two new, regional institutions in the ANZBCTG research program which will provide more women with access to clinical trials:
• Goulburn Valley Health, Shepparton, VIC (September 2012); • Wollongong Hospital, NSW (October 2012).
Peer-reviewed continuous grant support, including funding from the National Health and Medical Research Council and Cancer Australia, together with our donors and corporate supporters, provides vital funding to ensure that our commitment to designing and conducting clinical trials to the highest standards continues to deliver major advances in breast cancer treatment and patient care.
Members of the SAC and the Local Therapy, Supportive Care and Systemic Therapy SAC Subcommittees meet regularly to review all aspects of the ANZBCTG clinical trials program. An important role of these committees is to assess the scientific merit of new research concepts and, if endorsed by the committee, to support their development into new clinical trials. Ms Leonie Young and other members of the Consumer Advisory Panel contribute the consumer viewpoint and assist the SAC with the review of all new protocols and patient information material.
Significant progress was made on the development of two new clinical trials initiated by ANZBCTG investigators; a potential new collaboration with UK researchers on an international trial; and preparations to launch two new clinical trials through our existing international collaborations.
We thank all members of the SAC for their contribution, the investigators and their research teams for their continuing efforts, the hundreds of volunteers participating in ANZBCTG clinical trials, and also acknowledge the hard work of ANZBCTG staff who support the conduct of the clinical trials research program.
18 ANZBCTG Annual Report 2012-2013 Professor Robert Sutherland AO
We acknowledge the contribution made by the late Professor Robert Sutherland to the ANZBCTG Scientific Advisory Committee from its inception in 1992. He held many positions including: Director of the Cancer Research Program at the Garvan Institute of Medical Research for 27 years; inaugural Director of the Kinghorn Cancer Centre; and Senior Principal Research Fellow of the National Health and Medical Research Council. The ANZBCTG was fortunate to be guided by his expertise and unwavering commitment to research excellence. He was an international leader in cancer research and is sadly missed. In Summary
The year in review highlights solid achievements published in peer-reviewed scientific journals and the establishment of a new generation of trials investigating treatments increasingly tailored to the needs of particular subgroups of women diagnosed with breast cancer. The support of our patients who volunteer to take part in clinical trials is fundamental to the progress that has been made to date. The future of clinical trials will be built on developing technologies and emerging concepts for molecular control of tumour cell growth and requires a global effort to further clinical trials research.
Our research program is focused on relevant scientific questions on multiple fronts, including new approaches to treat triple-negative breast cancer, HER2-positive and HER2-negative breast cancer, and identifying new targeted therapies for metastatic breast cancer. Our clinical researchers take questions that arise in their clinical practices, answer them through clinical trials, and take this knowledge back to the clinic where it can benefit patients.
The ability to translate research into targeted treatments for patients requires collaboration between laboratory and clinical researchers, industry partners and government. More than 14,000 women have participated in our clinical trials and contributed substantially to improved survival for thousands more. The reduction in mortality from breast cancer is a direct result of the better treatments now available from clinical trials research.
New clinical trials will be launched and further analyses and follow-up of current clinical trials undertaken. Our engagement with eminent, skilled researchers and high quality scientific processes will ensure that the ANZBCTG continues to lead national and international research, making a vital contribution to improving breast cancer outcomes for every person.
We look forward to a new era of neo-adjuvant trials for discovery of new biomarkers of risk and as targets for new treatments. We can anticipate substantial progress in the near future.
Professor John F Forbes AM Director of Research
Associate Professor Nicholas Wilcken Chair, Scientific Advisory Committee
Associate Professor Prue Francis Vice Chair, Scientific Advisory Committee
Mrs Dianne Lindsay Head of Trials Management
ANZBCTG Annual Report 2012-2013 19 Clinical Trials Open for Participant Entry
Clinical trials research has contributed to improvements to treatments available to women with breast cancer and a significant reduction in breast cancer mortality rates over the last two decades. The ANZBCTG has made an important contribution to this research through its clinical trials research program. This year, 1,000 more women in Australia will survive their breast cancer diagnosis compared to 20 years ago.
Clinical trials are essential to identify if a treatment or treatment strategy is safe, effective and has the potential to save lives. All new medications and treatment strategies are rigorously tested through the clinical trials process before they are made widely available to the community and all research conducted by the ANZBCTG is carried out to the highest ethical and regulatory standards. More than 14,000 participants have taken part in ANZBCTG research.
Our research brings together more than 600 researchers in 84 institutions throughout Australia and New Zealand. This collaboration facilitates the conduct of clinical research in institutions with a wide geographical spread and ensures the efficient sharing of knowledge, expertise and resources.
The ANZBCTG enrolled 190 participants to five clinical trials during the reporting period. In addition, two trial substudies were open for participant entry, and the duration of follow-up of three international trials for women with early breast cancer was extended and will continue to collect valuable data.
ANZBCTG clinical trials open to participant entry in the reporting period were:
• IBCSG 22-00; • IBCSG 25-02 / BIG 3-02 Tamoxifen and EXemestane Trial (TEXT) – Bone Substudy; • IBCSG 35-07 / BIG 1-07 Study of Letrozole Extension (SOLE) and the Oestrogen Substudy (SOLE-EST); • ANZ 1001 Study of Oestrogen Receptor Beta and Efficacy of Tamoxifen (SORBET); • ANZ 1002 Post-operative Radiotherapy Omission in Selected Patients with Early breast Cancer Trial (PROSPECT); • ANZ 1102 / BIG 4-11 / BO25126 / TOC4939G Adjuvant Pertuzumab and Herceptin IN IniTial therapY of breast cancer (APHINITY).
20 ANZBCTG Annual Report 2012-2013 IBCSG 22-00
Low-dose cytotoxics as “anti-angiogenesis treatment” following adjuvant induction chemotherapy for patients with ER-negative and PgR-negative breast cancer.
Lead International Group: International Breast Cancer Study Group (IBCSG)
First ANZBCTG Participant Enrolled: 12 August 2003
IBCSG 22-00 closed to recruitment in Australia and New Zealand in December 2012. The ANZBCTG enrolled 95 of the 1,086 women participating in this trial internationally.
Some chemotherapy agents have been shown to reduce the formation of new blood vessels (angiogenesis), tumour growth and metastases spreading to different parts of the body. However, an optimal schedule has not been defined. Using lower doses of chemotherapy drugs for a longer period may be more effective, participants may experience fewer side effects, and there may be an increased benefit due to the longer treatment time.
This study will determine if low-dose chemotherapy with oral cyclophosphamide and methotrexate, given for 12 months following three to six months of standard chemotherapy, delays breast cancer recurrence more effectively than standard chemotherapy alone for women with breast cancer that is not hormone-sensitive.
In IBCSG 22-00, participants are randomised to one of two groups (A or B). Both groups receive an approved induction chemotherapy regimen. In group B, this chemotherapy regimen is followed by low-dose maintenance chemotherapy (cyclophosphamide and methotrexate) in tablet form, taken twice a week for one year.
“IBCSG 22-00 has achieved the international accrual target of 1,086 women. The results of this study may identify an effective, well tolerated and affordable treatment for patients with breast cancer that is not hormone-sensitive. I thank study participants, our investigators and their staff for their ongoing support.”
ANZBCTG Study Chair: Prof John F Forbes (Calvary Mater Newcastle)
Stratification
R S A Institution N Before induction U D A induction chemotherapy* O R chemotherapy Menopausal status M (pre vs post) begins or any G I time prior to S day 56** of the E A last cycle of induction Induction chemotherapy chemotherapy* R (AC/EC x 4 vs other regimens) T induction B I followed by Y O CM x 12 months N
* Approved induction chemotherapy regimens C: cyclophosphamide 50 mg/day orally continuously for 1 year (365 days) M: methotrexate 2.5 mg/twice a day orally days 1 and 2 of every week for 1 year (52 weeks)
** Amendment 3: November 2005 - extended the timing of randomisation
ANZBCTG Annual Report 2012-2013 21 IBCSG 25-02 / BIG 3-02 Tamoxifen and EXemestane Trial (TEXT) - Bone Substudy
A phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer.
Lead International Group: International Breast Cancer Study Group (IBCSG)
First ANZBCTG Participant Enrolled: 10 November 2009
TEXT completed recruitment in Australia and New Zealand in March 2011. The ANZBCTG enrolled 249 of the 2,672 women participating in this trial internationally.
This trial compares tamoxifen with the aromatase inhibitor exemestane, in premenopausal women who also have ovarian function suppression using the drug triptorelin. Women receive triptorelin plus tamoxifen or triptorelin plus exemestane. Tamoxifen and exemestane are two different types of drugs which limit the effects of oestrogen on cancer cell growth. Tamoxifen works by stopping oestrogen from fuelling cancer cells, while exemestane works by preventing the production of oestrogen.
Research has shown that exemestane works better in postmenopausal women because their ovaries are no longer producing oestrogen. TEXT will determine if suppressing ovarian function in premenopausal women (ie reducing oestrogen production) will allow exemestane to work in the same way as it does for postmenopausal women. This trial is designed for participants who should receive ovarian function suppression from the start of their adjuvant breast cancer treatment.
TEXT was supported by NHMRC Project Grants (2005-2006 – ID 351161 and 2008-2010 – ID 510788).
The effect of hormone therapy on bone health is not fully understood. A substudy, called TEXT-Bone, will assess the bone health of participants in TEXT at selected ANZBCTG centres. This substudy will measure bone density and analyse bone serum biomarkers in blood samples collected prior to, during and after treatment on TEXT, and assess changes over this time. The substudy closed to recruitment in December 2012. The ANZBCTG enrolled 26 of the 118 women contributing additional data for TEXT-Bone internationally.
“The TEXT trial presents a unique opportunity to study changes in the bone health of young women treated with ovarian function suppression for five years with either concurrent tamoxifen or exemestane (a steroidal aromatase inhibitor) and also assess the potential reversibility of any such changes after completion of trial treatment.”
ANZBCTG Study Chair: Assoc Prof Prue Francis (Peter MacCallum Cancer Centre)
22 ANZBCTG Annual Report 2012-2013 IBCSG 25-02 / BIG 3-02 Tamoxifen and EXemestane Trial (TEXT)
Patient Population Stratification * R S Premenopausal women Institution with histologically proven A Triptorelin x 5 yrs N U hormone receptor-positive + TAM x 5 yrs D (+_ CT) R breast cancer O CT (Y/N) M G ER >_ 10% and/or I PgR >_ 10% S E A Triptorelin x 5 yrs Candidates to begin Number of positive nodes T R + EXE x 5 yrs GnRH analogue from the (0; 1 or more) I (+_ CT) Y start of adjuvant therapy O N
CT: chemotherapy if used, should begin at the same time as Triptorelin. >_ 2 months duration if anthracycline is included; >_ 4 months if no anthracycline is included TAM: tamoxifen 20 mg daily po for 5 years** EXE: exemestane 25 mg daily po for 5 years** Triptorelin 3.75 mg IM injection every 28 days for 5 years, to begin from the start of the adjuvant therapy. * Randomisation prior to receiving any adjuvant systemic therapy. ** Tamoxifen or exemestane should start after adjuvant chemotherapy has been completed or at least 6-8 weeks after the initiation of triptorelin, whichever is later.
TEXT-Bone Substudy – Evaluating serial bone markers for bone remodelling, serial growth factors and bone mineral density.
TEXT-Bone collection time points R Years on TEXT E TEXT G 0 1 2 3 4 5 6 treatment I ongoing S (Tamoxifen T or R Exemestane A S S S S S and T D D D D D Triptorelin) I O N
TEXT-Bone participants are either enrolled at: - time of entry to the TEXT study, or - between the 3 and 36 month trial visits or - prior to the 60 month trial visit
S: Serum sampling time point D: DXA (dual-energy x-ray absorptiometry) scan time point
ANZBCTG Annual Report 2012-2013 23 IBCSG 35-07 / BIG 1-07 Study Of Letrozole Extension (SOLE)
A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following four to six years of prior adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, node-positive early stage breast cancer.
Lead International Group: International Breast Cancer Study Group (IBCSG)
First ANZBCTG Participant Enrolled: 19 February 2009
SOLE closed to recruitment in August 2012. The ANZBCTG enrolled 372 of the 4,884 women participating in this trial internationally.
After initial treatment for hormone receptor-positive breast cancer, standard treatment includes at least five years of endocrine (hormone or ‘anti-oestrogen’) therapy. For postmenopausal women, this treatment usually consists of tamoxifen or an aromatase inhibitor such as anastrozole or Ietrozole. However, half of all the recurrences in these women occur between five and 15 years from initial diagnosis, after the five years of endocrine therapy has been completed.
Research has shown that extending endocrine therapy beyond the usual five years may further prevent or delay breast cancer recurrence and prolong survival, but the best treatment schedule and duration is still unclear. One concern is that long term treatment with these endocrine medications may induce cancer cells to become resistant to the treatment thereby reducing their protective effect. Laboratory studies have shown that short breaks from letrozole treatment may reduce the development of such resistance by increasing the susceptibility of cancer cells to the letrozole when it is restarted after the break. The use of such an approach in patient management may increase the value of long term therapy.
The SOLE trial is designed to evaluate whether this approach does improve breast cancer outcomes. In the trial, patients will be allocated either continuous ‘extended’ letrozole for five years or letrozole with annual three-month treatment breaks, during the five years. Analysis after long term follow-up will indicate whether one treatment approach is better than the other.
The effects of aromatase inhibitor therapy on oestrogen (oestradiol and oestrone) levels and the link between changing oestrogen levels, treatment side effects and quality of life is not well known. This will be investigated in an additional substudy of the SOLE trial, called SOLE-EST. The substudy will assess the effect Ietrozole therapy, and a break from treatment, has on oestrogen levels and the possible correlation of these changes with quality of life and treatment side effects, in selected centres participating in SOLE. SOLE-EST closed to recruitment in July 2012. The ANZBCTG enrolled 30 of the 104 women contributing additional data for SOLE-EST internationally.
“The strong interest from women and clinicians globally in this study over the past few years continued throughout 2012 resulting in the recruitment of more than 4,880 participants when recruitment closed in August 2012, with ANZBCTG institutions making a big contribution with over 370 participants. The ANZBCTG also contributed nearly a third of the participants in the SOLE-EST substudy. Treatment and follow-up of participants continues in anticipation of results, which are still some years away. The first interim analysis is expected at the end of 2015.”
ANZBCTG Study Chair: Assoc Prof Jacquie Chirgwin (Box Hill and Maroondah Hospitals)
24 ANZBCTG Annual Report 2012-2013 IBCSG 35-07 / BIG 1-07 Study of Letrozole Extension (SOLE)
Patient Population Stratification * R Postmenopausal Institution A N LET continuously x 5 yrs D ER and/or PgR+ O Prior AET M early BC (AI(s) SERM(s)): I AI alone, SERM S 4-6 years of prior alone, both A Intermittent LET AET therapy SERM and AI T 9 m 9 m 9 m 9 m 12 m I Node-positive at O 0 12 24 36 48 60 initial diagnosis N
* Within 12 months of the last dose of prior endocrine therapy
AET: adjuvant endocrine therapy LET: letrozole 2.5 mg daily po for 5 years of adjuvant therapy Intermittent LET: 2.5 mg daily po for the first 9 months of years 1 through 4, followed by 12 months in year 5
Patients must have had proper local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease.
SOLE Estrogen Substudy (SOLE-EST) – Investigating changes in oestrogen levels and grip strength for participants in the SOLE trial.
SOLE-EST sample and measurement time points R over the first 12 months of SOLE trial visits E G 0 2 4 6 8 10 12 I 9 10.5 S T R A S T S S S I B G G O G N
S: serum sampling time point B: whole blood sampling time point G: grip strength measurement time point
ANZBCTG Annual Report 2012-2013 25 ANZ 1001 Study of Oestrogen Receptor Beta and Efficacy of Tamoxifen (SORBET)
A single arm phase II study of the efficacy of tamoxifen in triple negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) but oestrogen receptor beta positive metastatic breast cancer. Lead International Group: ANZBCTG First ANZBCTG Participant Enrolled: 14 March 2011 About 15% of breast cancers diagnosed are a type which is called ‘triple-negative’. There are less treatment options available for these cancers because they lack the three most common treatment targets known as receptors. As a consequence, women diagnosed with metastatic triple-negative breast cancer usually have a poorer prognosis. Currently, these women are treated with standard chemotherapy. While chemotherapy is often beneficial it is associated with significant side effects often compromising quality of life. Tamoxifen is a longstanding and successful hormone treatment for women with hormone-sensitive breast cancer, specifically oestrogen receptor (ER) and/or progesterone receptor (PgR) positive breast cancer. There are two different forms of the oestrogen receptor, oestrogen receptor alpha (ERα) and oestrogen receptor beta (ERβ). Researchers have measured ERβ in stored tissue from women who received treatment with tamoxifen. It was found that the women who had breast cancers that were ERα-negative, but ERβ-positive had longer survival times than those with tumours that were negative for both oestrogen receptors. This led to the hypothesis for SORBET, that tamoxifen may be an effective treatment for women with triple-negative breast cancers that are ERβ-positive. At least 20% of triple-negative breast cancers are ERβ-positive. It is hoped that SORBET will show that daily treatment with tamoxifen, a low cost and well tolerated drug, can control the growth and spread of triple-negative, ERβ-positive metastatic breast cancer. If this is proven, tamoxifen will be an attractive alternative to chemotherapy for these women. It may also lead to the investigation of tamoxifen as treatment for triple-negative, ERβ-positive early breast cancer. Results of this research will have implications worldwide in the treatment and management of women with this type of breast cancer. The ANZBCTG has enrolled four of the 66 women who will participate from 14 institutions throughout Australia and New Zealand (31 March 2013). The SORBET trial is supported by ANZBCTG Discretionary Funding. “The first 24 months of patient screening has been beneficial in informing us on the true number of patients possessing the specific tumour characteristics required for this trial, which is fewer than originally anticipated. A revision to the patient entry criteria based on information obtained from screening thus far has been undertaken and it is hoped that these changes along with an increase in the number of participating sites will lead to increased recruitment over the coming 12 months.” ANZBCTG Study Co-Chairs: Prof Kelly-Anne Phillips (Peter MacCallum Cancer Centre) Dr Belinda Kiely (Macarthur Cancer Therapy Centre)
Patient Population R S E Triple negative BC C G R I Metastatic disease *Confirmed E S Tamoxifen amenable to biopsy ER beta positive; T E 20 mg daily but ER alpha R Chemotherapy N and PgR absent A **PD or UT or CW currently not indicated I T At least one N I O measurable lesion G N
* Diagnostic metastatic tissue (FFPE block of 5 unstained slides) must be centrally confirmed ER beta positive. ** Tamoxifen 20 mg daily will continue until progressive disease (PD), unacceptable toxicity (UT), or withdrawal of participant's consent (CW).
26 ANZBCTG Annual Report 2012-2013 ANZ 1002 Post-operative Radiotherapy Omission in Selected Patients with Early breast Cancer Trial (PROSPECT)
A single arm phase II study using magnetic resonance imaging (MRI) to select patients with early breast cancer for omission of post-operative radiotherapy.
Lead International Group: ANZBCTG First ANZBCTG Participant Enrolled: 8 September 2011 For women diagnosed with early invasive breast cancer, standard treatment often involves breast conserving surgery followed by radiotherapy to reduce the risk of breast cancer returning to that breast (local recurrence). The need for radiotherapy depends on the risk of local recurrence occurring after surgery alone. If the chance is known to be minimal, there may be no need for radiotherapy. At present however, no sizeable group of patients with minimal risk of local recurrence after surgery alone has been identified, so the vast majority of women are recommended to have radiation. The treatment is usually given as a daily dose over three to six weeks and receiving radiotherapy treatment can lead to some short and longer term side effects. PROSPECT is a pilot clinical trial which is using a new technology, breast magnetic resonance imaging (MRI), in combination with review of pathological features of the breast tumour to prospectively identify women who may be able to safely avoid radiotherapy because their risk of local recurrence is very low. PROSPECT will fundamentally examine whether the abnormalities that contribute to the likelihood of local recurrence (and hence the need for post-surgery radiotherapy treatment) can be detected by breast MRI. Samples of the tumour tissue removed during surgery will be collected to further our knowledge about breast cancer. If it is found that radiotherapy can be omitted without a significant risk of local recurrence, it could alter the management of women with early breast cancer as well as decrease costs to the health care system. This may be particularly significant for rural and remote women, who frequently choose total mastectomy (breast removal) to avoid the need to have radiotherapy treatment that requires them to be absent from home. The PROSPECT clinical trial is now open at the Royal Melbourne Hospital, Victoria, and plans are well advanced to open it at more institutions in Australia and New Zealand. If this phase II trial demonstrates an acceptably low rate of local recurrence, a larger, multicentre, randomised phase III clinical trial will be conducted. The ANZBCTG has registered 50 women who have undergone pre-operative breast MRI and 21 of these women have been enrolled in the PROSPECT study (31 March 2013). The planned recruitment target for the PROSPECT clinical trial is 200 women. The PROSPECT trial is supported by ANZBCTG Discretionary Funding, with support from the National Breast Cancer Foundation and Cancer Council of Victoria. “We have seen a steady accrual rate over the past 12 months with a doubling in participant numbers since March 2012. Enthusiasm for PROSPECT among patients and clinicians remains high and we hope to expand patient access to PROSPECT by opening the trial at additional ANZBCTG institutions in the future.” ANZBCTG Study Chair: Prof Bruce Mann (Royal Melbourne Hospital)
Patient Population R Female, aged >_ 50 E G Histologically confirmed invasive, I unifocal, unilateral breast cancer <_ 20 mm S T standard treatment without pN0 or pN1 (mi) by sentinel node biopsy R radiotherapy or axillary dissection A T WLE >_ 2 mm margins (invasive and DCIS) I O Pre-op MRI* N WLE: wide local excision MRI: magnetic resonance imaging * nil/minimal, mild parenchymal enchancement only
ANZBCTG Annual Report 2012-2013 27 ANZ 1102 / BIG 4-11 / BO25126 / TOC4939G Adjuvant Pertuzumab and Herceptin IN IniTial therapY of breast cancer (APHINITY)
A randomised multicentre, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer.
Lead International Group: Breast International Group (BIG)
First ANZBCTG Participant Enrolled: 4 January 2012
Individuals with HER2-positive breast cancer have a poor prognosis when treated with standard chemotherapy regimens alone. HER2-positive breast cancer cells have an excess of growth receptor molecules on their surface. Similar to antennae, these receptors protrude from the cell, allowing specific molecules to attach and influence cell growth. About 20% of breast cancers have too many HER2 receptors on their surface; these are called ‘HER2-positive’ breast cancers.
Following initial treatment with surgery, the current standard of care in the treatment of HER2-positive early breast cancer is chemotherapy and the drug trastuzumab (Herceptin®). This treatment was proven effective by an earlier clinical trial, to which our researchers contributed, called HERA. The HERA clinical trial showed that treatment with trastuzumab approximately halved the risk of breast cancer recurrence in women with HER2-positive early breast cancer.
It is thought that the new drug, pertuzumab, will further reduce recurrence rates and improve the survival of people with HER2-positive breast cancer. Pertuzumab, a novel HER dimerisation inhibitor, specifically targets HER2 and may inhibit multiple HER signalling pathways. To this end the APHINITY trial will compare the current standard of care with the addition of the new HER2 targeted medication, pertuzumab. All participants will receive chemotherapy and trastuzumab and will be randomised on a 1:1 basis to also receive either pertuzumab or placebo. Trastuzumab and pertuzumab versus trastuzumab and placebo are given for a total of one year.
Participants will be reviewed at regular intervals to ensure their safety and follow-up will continue for 10-13 years. It is hoped that this trial will provide evidence of new and improved treatment options for people diagnosed with HER2-positive breast cancer.
APHINITY is undertaken in partnership with the Breast International Group (BIG), F. Hoffmann-La Roche Ltd and Genentech Inc.
ANZBCTG institutions have enrolled 109 women of the 3,956 participating in this trial internationally (31 March 2013). The study has closed for people with high risk, node-negative, HER2-positive early breast cancer but recruitment is still open for people with HER2-positive, node-positive disease. The study aims to enrol 4,800 participants, and it is expected that this goal will be reached during the second half of 2013.
“It is exciting that the APHINITY study will achieve its international accrual target this year, earlier than anticipated. We would like to thank investigators, their study teams and especially all trial participants for supporting this important international trial.”
ANZBCTG Study Chair: Assoc Prof Nicholas Wilcken (Westmead Hospital) ANZBCTG Study Co-Chair: Dr Marion Kuper-Hommel (Waikato Hospital)
28 ANZBCTG Annual Report 2012-2013 A T Patient Population * # Anthracycline Trastuzumab + Pertuzumab Stratification R based x 52 wks A S Primary invasive Nodal status chemotherapy + N breast cancer Trastuzumab + U D A T Type of Pertuzumab or adjuvant O Trastuzumab + Placebo R HER2 positive placebo x 52 wks chemotherapy M G centrally confirmed regimen I E S # Non- TC A R Suitable for Hormone anthracycline Trastuzumab + Pertuzumab treatment with receptor status T based x 52 wks Y 3-8 cycles I chemotherapy + O systemic Geographical Trastuzumab + TC adjuvant region N Pertuzumab or chemotherapy placebo Trastuzumab + Placebo x 52 wks
* Randomisation within 7 weeks of surgery, treatment to commence within one week of randomisation # Investigator selects protocol approved adjuvant chemotherapy regimen prior to patient randomisation
A: anthracycline based 3-4 cycles T: taxane based 3-4 cycles TC: docetaxel + carboplatin 6 cycles Trastuzumab: 8 mg/kg loading dose at cycle 1 then 6 mg/kg IV 3 weekly Pertuzumab: 840 mg loading dose at cycle 1 then 420 mg IV 3 weekly Placebo: IV 3 weekly Radiotherapy and/or endocrine therapy may be started at the end of adjuvant chemotherapy
ANZBCTG Annual Report 2012-2013 29 Clinical Trials Accrual Completed
Opened by the Participant accrual ANZBCTG completed
ANZ 0501 (LATER): A randomised trial of letrozole plus usual April 2007 March 2012 * care versus usual care without letrozole to prevent new breast cancer events in postmenopausal women who have completed a minimum of four years of adjuvant endocrine therapy for early, hormone-responsive breast cancer more than one year previous, and who are disease-free at trial entry.
ANZ 02P2 / IBIS-II (Prevention and DCIS): International June 2005 February 2012 * multicentre trials of anastrozole versus placebo in postmenopausal women at increased risk of breast cancer and tamoxifen versus anastrozole in postmenopausal women with hormone-sensitive DCIS.
ANZ 0802 / TRIO-CIRG 012: A multicentre, multinational, October 2009 December 2011 * randomised, double-blind phase III study of IMC-1121B plus docetaxel versus placebo plus docetaxel in previously untreated patients with HER2-negative, unresectable, locally recurrent or metastatic breast cancer.
IBCSG 34-05 / SWOG S0230 (POEMS): A phase III trial of April 2006 June 2011 * LHRH analogue administration during chemotherapy to reduce ovarian failure following standard adjuvant chemotherapy in early stage, hormone receptor-negative breast cancer.
IBCSG 25-02 / BIG 3-02 (TEXT): A phase III trial evaluating May 2004 March 2011 * the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer.
ANZ 0901 (TAILORx): A phase III, multicentre, multinational, October 2009 October 2010 * randomised trial of adjuvant chemotherapy plus hormone treatment versus adjuvant hormone treatment alone for patients with previously resected, axillary node-negative, invasive breast cancer with various levels of risk for recurrence.
ANZ 0702 / BIG 2-06 (ALTTO): A randomised, multicentre, June 2007 July 2010 * open-label phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination, in patients with HER2/ErbB2-positive primary breast cancer.
30 ANZBCTG Annual Report 2012-2013 Opened by the Participant accrual ANZBCTG completed
IBCSG 24-02 / BIG 2-02 (SOFT): A phase III trial evaluating the May 2004 June 2010 * role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer.
IBCSG 23-01: A randomised trial of axillary dissection versus June 2005 February 2010 * no axillary dissection for patients with clinically node-negative breast cancer and micrometastases in the sentinel node.
IBCSG 27-02 / BIG 1-02 / NSABP Trial B-37: A randomised July 2003 January 2010 * clinical trial of adjuvant chemotherapy for radically resected loco-regional relapse of breast cancer.
ANZ 0502 (NeoGem): A phase II trial evaluating the efficacy April 2006 July 2009 and safety of epirubicin and cyclophosphamide (EC) followed by docetaxel with gemcitabine (DG) (+ trastuzumab if HER2-positive) as neoadjuvant chemotherapy for women with large operable or locally advanced breast carcinoma.
ANZ 0601 / CIRG / TORI 010: A randomised phase II trial of June 2006 July 2008 double-blind, placebo controlled AMG 706 in combination with paclitaxel, or open-label bevacizumab in combination with paclitaxel, as first line therapy in women with HER2-negative locally recurrent or metastatic breast cancer.
IBCSG 32-05 / BIG 1-05 (CASA): Phase III trial evaluating November November 2007 the role of adjuvant pegylated liposomal doxorubicin (PLD, 2005 Caelyx®, Doxil®) for women (age 66 years or older) with endocrine-nonresponsive breast cancer who are not suitable for being offered a “standard chemotherapy regimen”.
IBCSG 26-02 / BIG 4-02 (PERCHE): A phase III trial May 2004 December 2006 * evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine responsive breast cancer who receive endocrine therapy.
IBCSG 30-04 / NCIC CTG MA.27: A randomised phase III trial May 2005 December 2006 * of exemestane versus anastrozole in postmenopausal women with hormone receptor-positive primary breast cancer.
ANZ 0001: A phase III trial to evaluate oral chemotherapy with October 2000 July 2005 capecitabine versus standard chemotherapy with CMF for advanced breast cancer.
ANZ 9602 (ATLAS): Adjuvant tamoxifen longer against shorter November March 2005 * clinical trial in early breast cancer. 1995
ANZBCTG Annual Report 2012-2013 31 Opened by the Participant accrual ANZBCTG completed
ANZ 0101 / BIG 1-01 / IBCSG 28-02 / B016348F (HERA): December January 2005 * A randomised three-arm multicentre comparison of one year 2001 and two years of Herceptin®, versus no Herceptin® in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy.
ANZ 0301 / BCIRG 103: A phase II, presurgical study to May 2003 December 2004 evaluate molecular alterations that occur in human breast cancer tissue and normal skin after short term exposure to ZD1839 (IRESSA™) and to correlate these alterations with pharmacokinetic parameters.
ANZ 0201 / 1839IL / 0067 (TIBER): A multicentre open-label, June 2002 September 2004 non-comparative, two-arm, phase II trial of ZD1839 (IRESSA™) in patients with hormone-insensitive (ER and PgR-negative) or hormone-resistant (ER and/or PgR-positive) metastatic or inoperable locally advanced breast cancer.
ANZ 0102 / BCIRG 007: A multicentre phase III randomised May 2002 March 2004 trial comparing docetaxel (Taxotere®) and trastuzumab (Herceptin®) with docetaxel (Taxotere®), carboplatin and trastuzumab (Herceptin®) as first line chemotherapy for patients with metastatic breast cancer containing the HER2 gene amplification.
IBCSG 17-98 / BIG 3-97 (HABITS): A randomised clinical trial August 1998 January 2004 concerning hormonal replacement therapy (HRT) after previous radical breast cancer treatment.
IBCSG 18-98 / BIG 1-98: A phase III study to evaluate letrozole October 1999 May 2003 * as adjuvant endocrine therapy for postmenopausal women with receptor (ER and/or PgR) positive tumours.
IBCSG 16-98 / BIG 2-97 (Intergroup Exemestane Study): November February 2003 Randomised double-blind trial in postmenopausal women with 1997 primary breast cancer who have received adjuvant tamoxifen for two-three years, comparing subsequent adjuvant exemestane treatment with further tamoxifen.
IBCSG 10-93: Surgical therapy with or without axillary node May 1993 December 2002 clearance for breast cancer in the elderly who receive adjuvant therapy with tamoxifen.
IBCSG 21-99 / NCCTG N9431: Menstrual Cycle and Surgical November December 2001 Treatment of Breast Cancer. 1999
32 ANZBCTG Annual Report 2012-2013 Opened by the Participant accrual ANZBCTG completed
IBCSG 20-98 / BIG 2-98: An intergroup phase III randomised August 1999 June 2001 * trial to evaluate the activity of docetaxel, given either sequentially or in combination with doxorubicin, followed by CMF, in comparison to doxorubicin alone or in combination with cyclophosphamide, followed by CMF, in the adjuvant treatment of node-positive breast cancer.
ANZ 92P1 / IBIS-I: A study to determine whether tamoxifen is April 1992 March 2001 * effective in reducing the incidence of breast cancer in women at high risk of developing breast cancer. This is a prospective double-blind placebo controlled trial.
IBCSG 15-95: Randomised trial of high-dose chemotherapy July 1995 March 2000 versus standard chemotherapy for high-risk, operable, stage II and stage III breast cancer in premenopausal and young postmenopausal patients.
IBCSG VIII: Adjuvant therapy in premenopausal and March 1990 October 1999 perimenopausal patients with node-negative breast cancer.
IBCSG 13-93: ACx4 followed by CMFx3 with or without a May 1993 August 1999 chemotherapy-free interval, +/- tamoxifen for premenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone.
IBCSG 14-93: ACx4 followed by CMFx3 with or without a May 1993 August 1999 chemotherapy-free interval, +/- tamoxifen versus toremifene for postmenopausal and perimenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone.
IBCSG IX: Adjuvant therapy in node-negative postmenopausal October 1988 August 1999 patients with operable breast cancer.
ANZ 9801 (ATAC): A randomised double-blind trial comparing April 1998 June 1999 * Arimidex® alone with Nolvadex® alone with Arimidex® and Nolvadex® in combination, as adjuvant treatment in postmenopausal women with breast cancer.
ANZ 9002 / Ductal Carcinoma In Situ (DCIS): A study to September December 1998 * compare the efficacy of additional tamoxifen, or radiotherapy 1991 to the breast, or both treatments, with no additional treatment following complete surgical excision of ductal carcinoma in situ of the breast.
ANZBCTG Annual Report 2012-2013 33 Opened by the Participant accrual ANZBCTG completed
IBCSG 11-93: Ovarian ablation followed by tamoxifen May 1993 November 1998 with or without four cycles of AC as adjuvant therapy for premenopausal, node-positive, hormone receptor-positive breast cancer patients who are suitable for endocrine therapy alone.
ANZ 9311: Phase III trial to compare the effect of a short April 1994 July 1998 * high-dose intensive course of chemotherapy with filgrastim support versus a conventional standard-dose course of chemotherapy in patients with advanced breast cancer.
IBCSG 12-93: Tamoxifen for five years versus toremifene for May 1993 February 1997 five years with or without chemotherapy as adjuvant therapy for postmenopausal and perimenopausal, node-positive, hormone receptor-positive breast cancer patients.
ANZ 8613: Phase III trial to evaluate addition versus substitution March 1987 September 1993 endocrine therapy in advanced breast cancer.
ANZ 8614: Phase III randomised trial to evaluate single agent January 1988 June 1993 mitozantrone (MTZ) versus combination cyclophosphamide, methotrexate, 5-fluorouracil, prednisone (CMFp) cytotoxic therapy in advanced breast cancer.
IBCSG VI–VII: Adjuvant therapy in node-positive patients with July 1986 April 1993 operable breast cancer.
ANZ 8811: Phase III trial to compare the efficacy of ovarian February 1989 October 1991 suppression treatment with LH-RH agonist, goserelin (Zoladex®), versus combined Zoladex® plus anti-oestrogen therapy, Nolvadex® (tamoxifen), in pre and perimenopausal patients with advanced breast cancer.
LBCT V: Perioperative and conventionally timed chemotherapy November December 1985 in operable breast cancer. 1981
ANZ 8101: Phase III trial to evaluate continuous versus June 1982 June 1985 intermittent combination chemotherapy in advanced breast cancer.
ANZ 8102: Phase III trial to evaluate optimal endocrine February 1982 June 1983 treatment with oophorectomy and tamoxifen in premenopausal patients with advanced breast cancer.
ANZ 7801: Phase III randomised trial to compare endocrine June 1978 November 1981 treatment (oophorectomy) versus cytotoxic chemotherapy (adriamycin plus cyclophosphamide) versus oophorectomy plus cytotoxic chemotherapy in premenopausal patients with advanced breast cancer.
34 ANZBCTG Annual Report 2012-2013 Opened by the Participant accrual ANZBCTG completed
ANZ 7802: Phase III trial to evaluate hormone therapy June 1978 November 1981 (tamoxifen) versus cytotoxic chemotherapy (adriamycin plus cyclophosphamide) versus hormone therapy plus cytotoxic chemotherapy as first line therapy in postmenopausal patients with advanced breast cancer.
LBCT I–IV: These protocols compared alternative adjuvant July 1978 September 1981 therapies combining endocrine and cytotoxic chemotherapy for patients with node-positive operable breast cancer.
* Participant follow-up continuing
ANZBCTG Annual Report 2012-2013 35 Communication Report
The Communication Plan has laid the foundation for us to be proactive in our communications, to be able to adapt to consumer behaviour and to meet the communication challenges we face in the future.
The number of people who visited our website via a mobile device increased from 4% in February 2012 to 22% in February 2013. This mobile phenomenon is not unique to the ANZBCTG. In fact, some say it’s only a matter of time before mobile internet will take over desktop internet usage.
That’s why the ANZBCTG’s Communication Plan has been so important. The Plan, the first for the Group, has laid the foundations for us to be proactive in our communications, to adapt to consumer behaviour and to meet the communication challenges we face in the future.
In year one of the Plan, we examined how we communicated with all stakeholders and developed a strategy of how we could improve and expand upon our existing communications. Our second year saw a rebranding of the ANZBCTG to provide a fresh, modern and dynamic look to the Group that we could then take forward. And in the third year of the Plan, which covers the reporting period for this Annual Report, we focused on internal communications. 2012/2013 Priorities
The Communications Plan from 2010-2014 prioritises our communication activities and outlines how we will achieve our communication goals. Improving internal communications within the Group’s departments to ensure communication opportunities for stakeholders are identified, shared and maximised has been a major focus in the reporting period. Other priorities have included:
• Develop media communication procedures and guidelines for media comment; • Improve the link between the activities of the ANZBCTG and the BCIA; • Improve the ANZBCTG and BCIA websites, based on the communication goals and needs of all stakeholders; and • Increase brand awareness to all stakeholders. Recognising Members and Staff
Our members and staff are the backbone of the ANZBCTG’s breast cancer clinical trials research program and we value their contribution and commitment to improving the lives of women and their families. This year, we
36 ANZBCTG Annual Report 2012-2013 have developed a number of initiatives to help recognise their involvement, including membership and staff length of service certificates.
Our staff enewsletter called ABREAST is distributed once a month to all staff across our three departments of Business Administration, Trials Coordination Department and the Breast Cancer Institute of Australia. Each month the enewsletter contains useful information such as new projects in each department, research updates, human resources and staff news.
The ANZBCTG Board of Directors has approved two new awards to add to our existing suite of awards. The Alan Coates Award for Excellence in Clinical Trials Research is open to members who have made an outstanding contribution to the ANZBCTG’s clinical trials research program and aims to assist the Awardee with their professional development. The Robert Sutherland Award for Excellence in Translational Research recognises translational researchers and their achievements and contributions to improved patient outcomes.
Utilising improvements made to the combined ANZBCTG and BCIA website, an online Membership Application Form is now available for new member applications. This online system streamlines the membership process for both applicants and ANZBCTG staff. IMPACT
IMPACT – Improving Participation and Advocacy for Clinical Trials – is an ANZBCTG consumer initiative. IMPACT aims to recognise the important contributions that women have made to breast cancer clinical trials research, provide members with reliable information about the progress of our research program and activities, and to educate members about the science of breast cancer and the conduct of clinical trials so they may become effective advocates for clinical trials research.
IMPACT activities this year have included launching a new online membership application form, new IMPACT brochure and improvements to online communications with IMPACT members such as an enewsletter and YouTube videos. IMPACT members also receive two newsletters each year, which provide an update on the progress of breast cancer clinical trials research and activities of the ANZBCTG. The Future
We are now in the fourth and final year of the current ANZBCTG’s Communication Plan and this year focuses on external communications. Our current communication projects are very exciting and will help us promote the ANZBCTG and its activities to the wider community.
This year will also be a time to reflect on the enormous advances the ANZBCTG has made in its communications and to start planning what our communication goals will be in the future. It has been fantastic to be the Group’s first Communications Manager and to have responsibility to drive these projects.
In the meantime, help us spread the word about our activities by joining us on one of our social media sites.
Join us on Facebook
Anna Fitzgerald Communications Manager
ANZBCTG Annual Report 2012-2013 37 Consumer Advisory Panel Report
Consumer Advisory Panel members are involved in all research undertaken by the ANZBCTG from concept development through to implementation and beyond.
In 1994, the ANZBCTG invited a breast cancer consumer advocate to become a member of its Scientific Advisory Committee. Five years later the Consumer Advisory Panel (CAP) was established to contribute to the research of the ANZBCTG, setting a precedent for best practice in clinical trials research in Australia.
CAP members are actively involved in all research undertaken by the ANZBCTG from clinical trial concept and development through to implementation, recruitment, analysis and follow-up. Two CAP members are members of the Scientific Advisory Committee (SAC) and each CAP member is a member of one of the SAC Subcommittees thus ensuring the perspective of women who have experienced breast cancer is represented. CAP members play a particularly important role in reviewing patient information and consent documentation which ensures patient materials for potential new clinical trial participants is clear and understandable.
Today, CAP has eight members from Australia and New Zealand, most of whom have participated in a clinical trial and all support evidence-based breast cancer research. Jennifer Bryce retired from CAP in December 2012 after more than 10 years. Jennifer made a significant contribution to the activities of CAP and the ANZBCTG’s research program and I sincerely thank her for her generosity, commitment and friendship. Earlier this year we welcomed new members Petrina Burnett from Perth and Leslie Gilham from Melbourne. I am privileged to lead CAP as the current Chair, and our members are Petrina Burnett, Raewyn Calvert, Sheryl Fewster, Leslie Gilham, Cheryl Grant, Linda Reaby and Carol Whiteside. Clinical Trial Activities
During the reporting period, CAP members reviewed the protocols and patient information material for three clinical trials under consideration by the SAC. One of these clinical trials was under development by the SAC Supportive Care Subcommittee, another is in the phase I, metastatic disease setting and will be led by ANZBCTG researchers. CAP also reviewed the final protocol and patient information material for an international clinical trial in the neo-adjuvant setting which will be coordinated in Australia and New Zealand by the ANZBCTG.
CAP members reviewed a survey which will be used to gather information from women who have taken an aromatase inhibitor as part of their breast cancer treatment. The survey seeks information about any joint or muscle pain symptoms or side effects they may have experienced, and whether any alternative or complementary therapy was taken and whether this was effective in relieving any symptoms.
38 ANZBCTG Annual Report 2012-2013 CAP members also reviewed the communications for women who took part in the Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) clinical trial, which advised of the ATLAS analysis published in The Lancet in March 2013. Advocacy Activities
CAP members have extensive networks within the cancer community, particularly as it relates to research and as a result they interact widely in relation to cancer centred activities. Many hold memberships on committees of other key breast cancer and cancer organisations bringing an informed perspective to CAP and vice versa. I am delighted to Chair the Cancer Trials Consumer Network (CTCN) which was established in 2011 to bring together consumers who, like our CAP members, also provide a consumer perspective to the research of other cancer clinical trials groups. Being able to share experiences, develop resources and mentor new consumers in this unique research area has been very rewarding. To this end, CAP members have shared their expertise through mentoring and education to assist new consumer advocates and during the past year, we have worked with the newly formed consumer advisory panel of the Australia and New Zealand Urogenital and Prostate Cancer CAP Members L-R: Raewyn Calvert, Sheryl Fewster, Carol Whiteside, Leonie Young, Trials Group (ANZUP). Petrina Burnett, Leslie Gilham and Cheryl Grant. Absent: Linda Reaby.
“Enhancing Consumer Engagement in Clinical Trials Research” was a project undertaken jointly between the Clinical Oncology Society of Australia (COSA) and Cancer Australia. CAP members participated in the project’s Steering Committee, the Curriculum Committee and also played a role in the teaching aspects of the completed project. This resource is now available on the Cancer Australia website to assist consumers who are actively involved in providing consumer input to clinical trials research groups or similar organisations in relation to research initiatives.
CAP members are actively involved in the ANZBCTG Improving Participation and Advocacy for Clinical Trials (IMPACT) Program. This membership program of women who have been diagnosed with breast cancer, many of whom have participated in an ANZBCTG clinical trial, provides information and updates specifically about breast cancer clinical trials research. We were delighted to welcome three consumers, Leslie Gilham, Maryanne Maher and Moana Te Oriwa, to the 2012 IMPACT Advocate Program held in conjunction with the ANZBCTG Annual Scientific Meeting.
Promotion of the ANZBCTG research program throughout the year is a key activity for CAP members. This includes speaking to the media in relation to current and specific research issues, community awareness activities for clinical trials research and guest speaker presentations and sharing personal stories for specific fundraising projects.
CAP members have a proven record in successful advocacy and a true commitment to the clinical trials research process and continual learning. This combined with our extensive networks, professional skills and experience, guarantees we are a valuable resource to ANZBCTG researchers and the pursuit of better outcomes for all women.
Leonie Young Chair, ANZBCTG Consumer Advisory Panel
ANZBCTG Annual Report 2012-2013 39 Fundraising Report
I am humbled by the generosity of our supporters and inspired by their personal motivations and commitment.
I am pleased to report that the Breast Cancer Institute of Australia (BCIA) has had a successful year with fundraising income exceeding $5 million for the very first time. I am humbled by the generosity of our supporters and inspired by their personal motivations and commitment.
When we first began fundraising in 1995, our goal was to provide sustainable, long term income for the ANZBCTG research program. Clinical trials may take several years to complete and it is essential to ensure that funding is in place to see a clinical trial through active recruitment and then to analysis, publication and follow-up. Funds raised by BCIA are crucial to the research program ensuring that our researchers continue to build on knowledge gained and are able to readily pursue new research opportunities for the benefit of the entire community.
We are fortunate to have many individual supporters and well known corporates who share our mission, vision and values and who help make research progress possible. It is their efforts which make the benefits of research real for women every day who are diagnosed with breast cancer.
Our supporter base is increasing with active strategies during the past year helping to encourage many new donors. They join a very special group of people, some of whom are now reaching 17 years of support. The style of our communications and their timing is a high priority as we listen and respond to our donors’ needs and requests. We strive to show our donors how their gifts are changing the lives of women and their families every day via our newsletters, letters and emails.
I take this opportunity to convey my sympathies to the families of our supporters who have sadly passed away during the past year. I also acknowledge many of them who generously remembered the BCIA in their will.
We are proud to work in partnership with Avon, Commonwealth Bank and The Australian Women’s Weekly. The strength of these partnerships, all over 16 years in duration, grows each day as these respected companies recognise that clinical trials research is a long term commitment but is crucially the proven path to saving more lives from breast cancer.
Collectively, these partnerships have helped to raise $18 million in research funding over the years and my sincere gratitude goes to Avon, its Representatives and customers; CommBank staff and customers; and The Australian Women’s Weekly, staff and customers; and the wider community for this wonderful outcome.
40 ANZBCTG Annual Report 2012-2013 Fundraising Report
Many of our fundraising projects during the reporting period, such as the 2013 Australian Women’s Health Diary and Tee Off golf events, have also had excellent results. So too have other community fundraising initiatives like Everyday Hero and I am pleased to bring some highlights of the year to you in the following pages. My thanks to all those who feature for sharing their stories and photos.
I also wish to thank the staff of the BCIA (pictured) for their efforts during the past year. As a small team, each person carries many duties and responsibilities which contribute to our overall objectives. Together we have achieved much and I thank them for their personal support.
The more funding we can secure the more clinical trials we can conduct and the sooner we can get more treatment options to the women who need them. It is this which drives our efforts to think beyond today and to grow, improve and adapt our fundraising activities so that our researchers can pursue the best new research free of funding constraints and with one goal in mind – to save more lives from breast cancer.
Thank you to all our supporters and please be assured that your commitment to our research is very much appreciated.
Julie Callaghan General Manager, Breast Cancer Institute of Australia
L-R: Anna Cummins, Leigh Hainsworth, Julie Callaghan, Tamar Carpenter, Breanna Edman, Sandy Morris, Vicky Tayler, Cheryl Dodds. Absent: Jenny Leggett and Kelly Martin.
ANZBCTG Annual Report 2012-2013 41 Fundraising Results and Highlights
Results
Income Income is raised from fundraising activities and returns on invested funds. In the 2012/2013 financial year, BCIA income increased by 19% to $6,623,760 with income from fundraising activities increasing by 15% to $5,571,707. The growth in fundraising income was largely attributable to an increase in Bequest income during the reporting period. BCIA has four main categories of fundraising income as shown below.
2012/2013 2011/2012 Donations $2,673,800 49% $2,485,641 51% Corporate Support $ 693,192 12% $ 631,550 13% Special Events and Projects $1,586,849 28% $1,684,237 35% Bequests $ 617,866 11% $ 51,489 1% FUNDRAISING INCOME $5,571,707 100% $4,852,917 100%
Expense To generate the 19% increase in BCIA income, expenses increased slightly to $1,893,471 with fundraising and administration expenses increasing to $1,313,023. We continually strive to keep all expenses to a minimum, and this year’s increase was expected and in line with new fundraising strategies to acquire new donors, consolidate fundraising activities and review resourcing. Investment in fundraising is essential as this sustains and increases income in the long term, and enables the research program to grow and our researchers to continue pursuing high quality research outcomes for the benefit of all women and our community overall.
2012/2013 2011/2012 Fundraising and Administration Expense $1,313,023 $1,205,469 Operating Expense $ 580,448 $ 533,082 EXPENDITURE $1,893,471 $1,738,551
BCIA cost to fundraise is 27% and is calculated using fundraising income (excluding Bequests) as per the NSW Charitable Fundraising Act 1991 and the Best Practice Guidelines of the Office of Charities, NSW Office of Liquor, Gaming and Racing.
Surplus All BCIA surplus funds are directed to the ANZBCTG research program to support the conduct of current research and the planning, development and implementation of new breast cancer clinical trials and related research activities. In the 2012/2013 year, BCIA surplus funds increased 23% to $4,730,289.
2012/2013 2011/2012 Income $6,623,760 $5,573,243 Expense $1,893,471 $1,738,551 SURPLUS $4,730,289 $3,834,692
42 ANZBCTG Annual Report 2012-2013 Highlights
The generosity of our community via Individual Giving provides our researchers with opportunities to participate in practice-changing international research and to develop and implement their own research concepts into clinical trials, for the benefit of women in Australia and New Zealand.
Our donors throughout Australia gave generously in the 2012/2013 financial year responding to our newsletter newsletter Edition 29 Edition 28 imagine Summer - Autumn 2013 Winter - Spring 2012 letters, newsletters and emails. Many people joined a world without breast cancer imagine our Regular Giving Program and now provide a a world without breast cancer regular, monthly gift. New communication materials will be a focus in the coming year to ensure these
donors are acknowledged and kept informed of the in this edition 2. From John Forbes 3. Our women leading the way in this edition Research update research they are supporting. 4-5. 2. From John Forbes 6. Clinical trial open 3. Avon Christmas
7. 2013 Diary coming Baubles soon 4-5. Research update 8-9. Researchers working 6. Heroes together, Avon 7. Tee Off 10-11. Successful fundraising, In Memoriam, Bequests 8-9. Supporters in action National recognition, The is an important activity and 12. 10-11. Supporter stories, Annual report Bequest Program 1 Noni B, Bequests,
ere with her In Memoriam ant in LATER - Cheryl, pictured p harticip 12. daughters, is a 2013 Diary information is regularly provided to donors about see story Page 3.
leaving a gift in their will. For many of our donors, 1 leaving a bequest ensures that their commitment to our research continues beyond their lifetime. Information is also regularly sent to solicitors and other relevant legal publications to assist people when making or updating their wills.
Income from Bequests increased significantly this year and we are very grateful to the following individuals, many of whom were long term supporters of the BCIA:
Estate of the late Colin Michael Parker Estate of the late Kathleen Noel Cotes Estate of the late Mary Christine Lygo Estate of the late Elaine Dawn Sweetman Estate of the late Margaret Kathleen Balchin Estate of the late Pauline Monica Smith Estate of the late Walter Donald Couper Estate of the late Joyce Meryl Glynn Estate of the late Anne Carroll Estate of the late John Barry Thomas Turnbull
Two major fundraising activities in the reporting period brought over 9,000 new supporters to the BCIA. A new Direct Mail Campaign featuring Natalie Donnelly, a young mother who was diagnosed with breast cancer at age 44, was successful. Many new donors responded to the need for more clinical trials to provide new treatment options for every person diagnosed with breast cancer.
Natalie Donnelly pictured with her husband and son.
ANZBCTG Annual Report 2012-2013 43 The 2012 Mother’s Day Research Appeal was also a success with many new donors giving a gift to breast cancer research in addition to, or in lieu of, a Mother’s Day gift for their mother. Response to the Appeal was positive with many heartfelt messages left on our website message board.
“ I can’t think of a better way to express my love for my mother and my girlfriends while supporting this wonderful cause.” Karen
“ I am donating as my Mum has been one of the lucky ones to beat breast cancer. I love you Mum and look forward to spending Mother’s Day with you!!! xoxooxoxo” Adam
“ I lost my mum to breast cancer seven years ago and I think this is the perfect way to acknowledge her on Mother’s Day.” Kara
“ My mother, mother-in-law and I have suffered breast cancer. I now have a granddaughter (5 months) whom I don’t want to suffer from it in the future.” Michelle
“ It was the only thing that my wife wanted for Mother’s Day. It helps our children appreciate the importance of research and the generosity of giving.” Steve
“ We love our Mum very very much and if research can help our Mum or anyone else’s Mum to live a healthier and happy cancer free life it is all worthwhile.” Zoe
“ This is a ‘perfect gift’ for Mum on Mother’s Day. My Mum knows I have thought of her, plus the research will help other mothers and daughters.” Shendelle
44 ANZBCTG Annual Report 2012-2013 Avon has been a generous corporate supporter for more than 17 years, donating a remarkable $7.9 million to the ANZBCTG over this time. In the 2012/2013 year, Avon donated $550,000 raised via sales of Avon Pink Ribbon and Kiss Goodbye to Breast Cancer Products (shown below). Avon Representatives work tirelessly to promote and sell these products to Avon customers receiving no commission on the sales.
In addition, Avon conducted a special Christmas Bauble campaign throughout Australia and New Zealand to help increase awareness of the ANZBCTG research program and the vital role Avon plays in supporting this program. Giant Avon Christmas Baubles were displayed in capital cities, and the community was encouraged to take photos with the bauble and post them on the Avon Facebook page for their chance to win a trip to the Avon Walk for a Cure in New York, USA.
Professor John Forbes with an Avon Kerri-Anne Kennerley with Avon Representatives. Representative in Sydney.
Avon Representatives showing their support in Sydney. Associate Professor Jacquie Chirgwin in Melbourne.
ANZBCTG Annual Report 2012-2013 45 Avon is also one of three major sponsors of our Australian Women’s Health Diary. The 2013 edition was very successful raising net income of $900,000 for the ANZBCTG research program bringing the overall monies raised to $9 million. A good sales rate was achieved again this year showing that demand for the diary remains strong. We sincerely thank all of our customers and appreciate the positive feedback we received for the 2013 edition.
The Australian Women’s Weekly has generously produced every edition of the diary on our behalf and contributed enormously to its success. Led by Ms Michelle Endacott, the Weekly’s Managing Editor, the diary team - Ellen, Darlene, Stephanie and David - work tirelessly to provide relevant and up to date health information, presented in a stylish, practical format.
We were delighted to welcome the support of Lisa Wilkinson (pictured below), co-host of the Nine Network TODAY Program, for our 2013 edition. Lisa featured in the foreword and in all of our promotional communications and together with the Nine Network helped take our diary to a wide, national audience.
“I find it interesting to read about women’s health issues every time I turn a page of the diary. Very educational.” Vivienne
“ Breast cancer unfortunately runs in my family. I love that I’m helping by purchasing a diary and also it’s a really good diary, the best I have found! ” Amy
“ I have four sisters and I am buying a diary for each of them and one for myself to motivate us to exercise, eat well and live longer.” Celia
“ I look forward to reading my weekly little health notes in the diary. They keep me going! ” Crystal
“ The diary has an attractive and practical format. It features relevant information while my purchase helps the breast cancer cause.” Angela
“ I have been buying The Australian Women’s Health Diary for years and it is a fantastic diary with everything I need and the money goes to a great cause.” Kellie
46 ANZBCTG Annual Report 2012-2013 Commonwealth Bank is also a major sponsor of our Australian Women’s Health Diary helping to produce, sell and promote each edition. Many diaries were sold in branches nationally and to CommBank staff who also received a bonus lipstick thanks to Avon. Commonwealth Bank women’s health ambassador, Maggie Beer, appeared on Mornings with Sonia and David on the Nine Network to promote the diary. Following this she signed copies of the diary for CommBank staff and the general public at Darling Park in Sydney.
Our partnership with Commonwealth Bank first began in 1995, and since that time they have helped to raise $3.1 million for our research program. On 2 October 2012, CommBank turned its logo pink on their internal intranet site. We are very grateful to Commonwealth Bank Chief Executive Officer, Mr Ian Narev, who provided his personal support for our diary in his weekly email to staff.
In addition to selling and purchasing the diary, we congratulate and thank CommBank staff for their ongoing generosity and commitment to our research. Many events were held by CommBank staff throughout the year, and during October 2012 staff at branches nationally held pink-themed events which raised $130,000.
Newcastle area CommBank staff present a donation to BCIA staff for activities conducted during Surfest.
Maggie Beer signing copies of the diary at Darling Park Staff of the Ballarat branch in VIC who made 600 cupcakes Sydney. for their pink morning tea.
Staff of the Bank’s Third Party and Mobile Banking Group Staff of the Redcliffe branch in QLD who held a bake stall walked up Mt Warning to raise funds for BCIA. and raffle.
ANZBCTG Annual Report 2012-2013 47 Many people throughout Australia choose to support the BCIA when they participate in a major sporting event, such as the Sydney City to Surf. Through the peer to peer online fundraising platform, Everyday Hero, people asked family, friends and colleagues to sponsor their participation helping to raise $47,000 for BCIA during the reporting period. We are grateful to our “Heroes” for their efforts, and thank those who shared their personal motivations and experience with us.
Louisa, pictured second left with her Emma Greenley (left) with Kevin Rudd and her friend Angela in the 2012 Bridge to Brisbane. team “Rapid Thigh Movement”, wanted to support her mum.
We completed the Bridge to Brisbane and successfully exceeded our fundraising target of $5,000 by raising $5,785 so far. I am so happy that we raised so much and am touched by the generosity of people. My mum is currently battling aggressive breast cancer, so my whole team are glad we could help the Breast Cancer Institute of Australia and support the wonderful work you guys do!
Louisa’s mum sadly passed away a few months after the event. Team “Mighty from Nineteen” in the 2012 Bridge to Brisbane.
Hayley Stevens in the 2012 Canberra Fun Run. Zoe Bromham and Paula in the 2012 Gold Coast Airport Marathon.
48 ANZBCTG Annual Report 2012-2013 Natalie, pictured with her family, received some shocking news one week prior to the event.
Quite simply I wanted to take part in the 12km walk as I have never ever done anything like this before and had been going to the gym to get fitter. The charity Loridana Oudicho in the 2012 City to Surf. for breast cancer I chose was due to my mum being diagnosed five years previously, (she has now been given the five year all clear). About one week before the City to Surf I was also diagnosed with breast cancer. It was completely out of the blue as I was only 42 years old. This made me even more determined to complete the walk which I did in just over two hours with my husband, 12 year old daughter and several friends. Little did I know that my cancer involved a lumpectomy in September after the race followed by a mastectomy in October. Treatment is still ongoing. I was Team “Mighty from Nineteen” in the 2012 Bridge not ashamed to use my position to collect to Brisbane. donations for the charity and was very pleased to reach above my target of $1,000. Todd participated for his aunt, and to It was an amazing experience to be part support research into new treatments. of the walk and see so many others taking part. I intend to compete again next year Like many Australians, my family has been and for as many years as I am able to. affected by breast cancer. I have watched my Aunt battle through three bouts of breast cancer. No person should have to endure such pain and suffering. In spite of advances in modern medicine, we are still unable to prevent cancer or provide painless and effective treatment. Organisations like BCIA are helping to change that. If pounding the pavement for an hour and fundraising will help continue the work of BCIA then that is as good a reason as any to participate in the Sydney City to Surf. Anna Fitzgerald from team “Blister Sisters” pictured with two fellow competitors.
ANZBCTG Annual Report 2012-2013 49 Tee Off for Breast Cancer Research events were held in 137 golf clubs nationally during the reporting period. These clubs, together with other clubs who made a donation, helped to raise $150,000. This wonderful result is testament to the special motivation club members have for this cause, many having had personal experience of breast cancer.
The following clubs were particularly successful in their fundraising in 2012:
• Carpentaria Golf Club QLD $8,450.00 • Macquarie Links International Golf Club NSW $8,376.86 • Richmond Golf Club and Richmond Club NSW $7,230.00 • Mornington Golf Club VIC $6,038.90 • The Australian Golf Club NSW $4,000.00
Each year, clubs large and small bring their own unique theming and activities to their day of golf. We love to receive anecdotes and photos from these events, and many clubs report that the success of their event has been due to the generosity of the local community, business sponsors, the club and their members.
Women’s Golf Nowra NSW. Macquarie Links International Golf Club NSW.
Alyangula Golf Club NT. Richmond Golf Club NSW. Wendy Wallis of Wauchope Golf Club NSW.
Alyangula Golf Club NT. Carpentaria Golf Club QLD.
50 ANZBCTG Annual Report 2012-2013 Gifts received In Memory when a family member or friend dies are a meaningful and lasting way of commemorating their life and supporting breast cancer research. We sincerely acknowledge donations made this year in memory of:
Mr Stuart Addison Ms Anthea Ford Mrs Lorna Papple Mrs Helen Aitken Mrs Megan Gandfors Mrs Ariamalar Paranerupasingham Mrs Joyce Aitken Mrs Helen Louise Elizabeth Giblett Mrs Christine Joan Parker Mrs Hilary Bach Mrs Vera Giblin Ms Felicity Parry Mrs Beris Bailey Mrs Thelma Giddings Mrs Leela Perera Mrs Beryl Baillon Mrs Patricia Glanville Ms Stephanie Pincini Mrs Christine Bateman Mrs Pauline Gooden Ms Evelyn Joyce Porter Mrs Madeline Baumgarner Mrs Winifred Gray Mrs Phyllis Power Mrs Ivy Bird Mrs Rachel Gray Mrs Debborah Queen Mrs Dinah Blake Mrs Norma Greig Mrs Noelle Ralph Mrs Margaret Boys Mrs Francesca Gwyther Mrs Margaret Reid Mrs Kerry Bramwell Mrs Rita Haines Mrs Marion Rigden Mrs Christine Bridges Ms Debra Louise Harper Ms Catherine Robinson Ms Karen Brown Miss Margaret Hauw Ms Marie Shaw Mrs Yvonne Buttner Mrs Alison Hickman Mrs Valda June Sherlock Ms Betty Kay Cardinale Mrs Jean Hind Mrs Jan Simpson Mrs Dorothy Carroll Mrs Helen Hipsley Mrs Laura Sokol Ms Alma Chalmers Mr Ting Shun Ho Miss Athena Spliadis Mrs Beatrice Ching Mrs Philomena Hopkins Mrs Lorraine Stewart Mrs Yeuk Chong Ms Denise Joan Howarth Ms Joaquina Romona Suckling Mrs Magdalene Clark Mrs Joyce Hunter Mrs Toni Summers Ms Therese Clarke Mrs Elizabeth Jackson Ms Linda Summers Mrs Irene Clarke Ms Linda Jameson Mrs Beryl Symonds Mrs Stella Cleland Mrs Barbara Jameson Mrs Ingrid Todd Mrs Karen Coates Mrs Veronica Januszke Ms Ninette Trent Mr David Collard Ms Catherine Johnstone Ms Merran Trotter Mr Peter Michael Collins Mrs Joan Jones Mr Mark Turnbull Ms Christine Cooper Mrs Margot Kirsch Ms Valerie Tyndall Mrs Winifred Coulter Mrs Marie Loader Ms Agnes Vajda Mrs Terri Craig Mrs Angela Ludowici Mrs Sharon Van der Meer Ms Anne Maree Cruise Mrs Michelle Lyra Mrs Judy Walker Mrs Diane Cummins Mrs Alicia Mackison Mrs Joyce Wallach Ms Kate Davey Mrs Merle Marshall Mrs Margaret Webb Mrs Soona Devitre Mrs Karen Mart Mrs Kate Webb Miss Patricia Duggan Ms Helen Mayne Mr Ian Wickson Mrs Betty Ellerton Mrs Eva Nederman Mrs Margaret Willis Mrs Lorna Elliott Ms Natalie Newton Mrs Elsie Joyce Wood Ms Barbara Emmerson Mr Dennis Oates Mrs Sandra Woodhouse Ms Zahra Farag Ms Deirdre O’Flynn Mrs Pam Woods Mrs Robyn Feldman Mrs Wendy Osborn Mrs Monika Zachariasz Ms Olivia Flavell Ms Elena Pacor
“ My sister died from breast “ In memory of my Mum, “ For my Aunty, an inspiration, cancer when she was 40 missing you as always.” a fighter and a wonderful leaving behind four beautiful Vanessa woman who unfortunately young children. I proudly lost her long battle. We love support the wonderful work and miss you so much! ” that BCIA is doing.” Laura Ross
ANZBCTG Annual Report 2012-2013 51 Community Fundraising has been successful this year and we thank all those individuals, community groups and clubs, schools and businesses for holding special events to raise funds for BCIA. These events, large and small, take dedication and commitment to successfully organise and we are grateful to the following for their support:
Kerri-Ann Dennis, Wallsend NSW Tahnee Duncan, Rathmines NSW Anna Foster, Maryborough QLD Samantha Jarvey, Bardwell Valley NSW Robyn and Wendy March, Valentine NSW Gail Lilli, Padstow NSW Faye Purnell, Buttaba NSW Jasmine Wachtel, Hillarys WA Lynette J Wieser, Baulkham Hills NSW
Bayview Golf Club, Mona Vale NSW The Cartridge Recycler Pty Ltd, Sydney NSW Church of the Good Shepherd Handcraft Group, Cardiff NSW Elermore Vale Lions Club Members at their Pink on the Rink bowls day. Committee of La Madonna Del Sudore, Kedron QLD Commonwealth Bank of Australia – 96 King William Branch, Adelaide SA Commonwealth Bank of Australia – Group Corporate Services Charity and Community Committee, Sydney NSW Commonwealth Bank of Australia – Local Business Banking, Newcastle NSW Commonwealth Bank of Australia – Shepparton Branch, Shepparton VIC Commonwealth Bank of Australia – Southern Area, McLaren Vale SA Commonwealth Bank of Australia – Third Party and Mobile Banking Group Dungog Sunshine Club, Dungog NSW Embroiderer’s Guild Queensland, Yeppoon QLD Filipino Community of the Hunter Region Inc, Mayfield NSW Representatives from Madgwicks law firm present a cheque to Associate Professor Jacquie Chirgwin.
James Kindle, Michelle Makin and David Kindle from The Sewing Bees of Port Stephens pictured with Vicky Noni B present a donation to Julie Callaghan. Tayler from BCIA.
52 ANZBCTG Annual Report 2012-2013 Friends Abreast Committee, Bakery Hill VIC Gorokan High School, Lake Haven NSW Griffith Breast Cancer Support Group, Griffith East NSW Hamilton Western District Health Service, Hamilton VIC Handknitters Guild of Victoria, Laburnum VIC Lions Club of Elermore Vale, Jesmond NSW Loreto College, Marryatville SA Madgwicks Lawyers, Melbourne VIC Maitland Patchwork Quilters, East Maitland NSW Maroba Lodge, Waratah NSW Moonta Memorial Bowling Club ‘Night Owls’, Moonta SA Mount Waverley Ladies Probus Club, Mount Waverley VIC Noni B Limited, Kings Park NSW North Coast Equestrian Club, Coffs Harbour NSW Nurses of Sorrento Ward – Mornington Centre, Members of the Bayview Golf Club dress in pink for Mornington VIC their event. Patrons of the Sacred Heart Housie, Newcastle NSW Pink Petticoat, Geraldton WA Rockhampton East Rotary Club ‘Rotaryannes’, Rockhampton QLD Sewing Bees, Salamander Bay NSW St George Masonic Club Ltd, Mortdale NSW St Joseph’s Craft Group, North Mackay QLD St Michael’s Family Centre, Baulkham Hills NSW Swansea Caves Rugby Leagues Club, Swansea NSW Swansea Workers Co-Op Club, Swansea NSW Trans-Tasman Business Circle, Bondi Junction NSW Ulysses Motorcycle Club – Bunbury, Bunbury WA Warners Bay Netball Club Inc, Warners Bay NSW Woolworths Hilton, Hilton SA
Jasmine Wachtel and friends at her fundraising BBQ.
Samantha Jarvey pictured with her mum. Gail Lilli celebrates with friends at her Pink Party.
ANZBCTG Annual Report 2012-2013 53 Members of the Dungog Sunshine Club.
Students from Gorokan High School show their support. Colin Law from the Commonwealth Bank pictured with BCIA staff at Surfest.
Parents and staff at St Michael’s Preschool and Long Day Care enjoying their morning tea.
Gail Lilli celebrates five years cancer free.
54 ANZBCTG Annual Report 2012-2013 Many people generously encourage their friends and family to make an In Celebration donation to BCIA in lieu of special occasions, like birthdays. We acknowledge the following people who chose to support their special occasion in a truly giving way:
Mrs Bronwyn Anderson Birthday Mrs Marilyn Ash Birthday Mrs Bernadette Attard 70th Birthday Ms Margaret Baker 70th Birthday Mrs Suzanne Booth 5th Anniversary of my operation Mrs Balbina Brillhart 70th Birthday Ms Wendy Britton 50th Birthday Ms Sarah Butcher Birthday Ms Beth Cooney 60th Birthday Mrs Diane Douglas Christmas Mrs Val Dudley Birthday Ms Heather and Ms Ariah Dukorski Thank You David and Helen Layman (seated at left) celebrate their joint 70th Birthday with family and friends. Mrs Betty Evans Birthday Mrs Norma Fiedler Christmas Ms Natasha Fragassi Birthday Ms Inge Herrmann 80th Birthday Ms Danielle Hirst Birthday Ms Raelene Kernick 70th Birthday Mr and Mrs David and Helen Layman Joint 70th Birthday Mrs Kathy Liner 60th Birthday Mr Mick Maher 50th Birthday Mrs Jennesse Mallaby 30th Birthday Mrs Kay McKee Birthday Ms Beverley Morrisby Birthday Ms Leah Morrisby Birthday Ms Val Murphy 90th Birthday Ms Francesca Politi 80th Birthday Mr and Mrs Len and Cecile Radomsky 50th Wedding Anniversary Mr Matthew Robinson Wedding Mrs Caiti Shairp Birthday Ms Freda Simons 70th Birthday Ms Kerry Smith Christmas Ms Rhonda Smith Christmas Mr and Mrs Brian Wallace Christmas Mrs Carol-Anne White 50th Birthday / In memory of best friend Mrs Edi Zanardo 50th Birthday Farrer Tennis Group Christmas Newcastle Private Hospital ICU Medical Team In appreciation of their work
“Our usual practice is not to give Christmas “ Many members of our family have been presents but to donate to BCIA the amount struck by this disease so we applaud the that would otherwise be spent.” work you do and pray for a cure.” The eight friends of the Farrer Tennis Group David and Helen Layman
ANZBCTG Annual Report 2012-2013 55 Governance
Board of Directors 1 April 2012 to 31 March 2013
Professor Frances Boyle AM
Professor Frances Boyle AM was elected to the ANZBCTG Board of Directors in 2001 and elected Chair of the Board in July 2012. Professor Boyle chaired the ANZBCTG Scientific Advisory Committee for five years until November 2010. She is a Medical Oncologist and is Professor of Medical Oncology at the University of Sydney and Director of the Patricia Ritchie Centre for Cancer Care and Research at the Mater Hospital, Sydney. Professor Boyle is also a Board Member of the Breast Cancer Network Australia. She has close links with health professionals across the spectrum of cancer care and with the medical teaching program of the University of Sydney. Professor Boyle was honoured in 2008 with Membership of the Order of Australia for work with professional and community organisations involved in cancer care and research. Associate Professor Jacquie Chirgwin
Associate Professor Jacquie Chirgwin was elected to the ANZBCTG Board of Directors in 2003, was Chair from 2005 to July 2012 and is now Deputy Chair of the Board. She is also a member of the ANZBCTG Scientific Advisory Committee and has had a long commitment to clinical research spanning more than 20 years. Associate Professor Chirgwin is a Consultant Medical Oncologist at Box Hill and Maroondah Hospitals in Victoria and established breast cancer clinical trial departments in these hospitals and at the Breast Unit at Mercy Private Hospital in East Melbourne. She is Conjoint Associate Professor at the University of Newcastle and past Chair of the Victorian Cooperative Oncology Group Breast Cancer Committee and a member of the Reference Group of the North Eastern Melbourne Integrated Cancer Service (NEMICS). She is also a member of several international cancer research bodies. Professor Stephen Ackland
Professor Stephen Ackland was elected to the ANZBCTG Board of Directors in 2007 and appointed in 2010. He is Conjoint Professor at the University of Newcastle, a Medical Oncologist and Senior Staff Specialist in the Medical Oncology Department of the Calvary Mater Newcastle Hospital and Director of the Hunter Cancer Research Alliance. Other professional activities include Director of the NSW Cancer Council, Editor-in-Chief of the Asia Pacific Journal of Clinical Oncology and member of many international cancer research bodies.
56 ANZBCTG Annual Report 2012-2013 Associate Professor Ian Campbell ONZM
Associate Professor Ian Campbell was elected to the ANZBCTG Board of Directors in 2001 and is a member of the ANZBCTG Scientific Advisory Committee. He is a Surgeon at Waikato Hospital in Hamilton, New Zealand. His academic appointment is with the University of Auckland School of Medicine, Waikato Clinical School and is based on breast cancer clinical trials work with a special interest in local therapies and endocrine treatments. Associate Professor Campbell is Chairman of the Waikato Breast Cancer Trust; he was Chairperson of the NZ Guidelines Group team producing the NZ Guidelines for Management of Early Breast Cancer and currently chairs the NZ Breast Cancer Working Group developing NZ Standards of Care for Breast Cancer. He is a member of the Breast Surgeons of Australia and NZ Audit and Post Fellowship Training Subcommittees. Mr Michael Hamar
Mr Michael Hamar was appointed to the ANZBCTG Board of Directors in March 2011. Mr Hamar is a consultant in the field of risk management and banking. His expertise is in the fields of finance, risk management and corporate governance. He retired in 2009 from the National Australia Bank, where he was a member of the Group Executive Committee and Group Chief Risk Officer. Prior to that, Mr Hamar had a 35 year career in banking and finance, including positions with the Commonwealth Bank of Australia, JP Morgan Chase and Bank of America, in Europe, the US, Asia and Australia. He holds Masters degrees from Cambridge University and the University of Chicago. Professor David Joseph
Professor David Joseph was elected to the ANZBCTG Board of Directors in July 2011. He is a Clinical Professor of the School of Surgery at the University of Western Australia and Radiation Oncology Consultant at Sir Charles Gairdner Hospital and Genesis Cancer Care Bunbury. Professor Joseph has been involved with the ANZBCTG for over 20 years, is a member of the Scientific Advisory Committee and involved in publications with the International Breast Cancer Study Group. He is the Co-Chair of the International TARGIT Study, Australian Chair of the RADAR Trial, founder of The Western Australian Tissue Network and has ongoing research with the National Translational Cancer Research Network, University of Oxford UK. His specialty treatments include HDR and LDR Brachytherapy, Stereotactic Radiosurgery and Intra-Operative Radiotherapy and he is actively involved in research and innovative treatments for patients with various malignancies. Professor Geoffrey Lindeman
Professor Geoffrey Lindeman is a Clinician-Scientist elected to the ANZBCTG Board of Directors in 2003 and is also a member of the ANZBCTG Scientific Advisory Committee. He is a Medical Oncologist at the Royal Melbourne Hospital, where he heads the RMH Familial Cancer Centre. Professor Lindeman is also Joint Head of the Stem Cells and Cancer Division at the Walter & Eliza Hall Institute of Medical Research in Melbourne. He is a NHMRC Principal Research Fellow and is Clinical Director of the ACRF Centre for Therapeutic Target Discovery and TransBCR (a NHMRC-funded Centre of Research Excellence in Translational Breast Cancer Research). Professor Lindeman is also a member of the Executive of kConFab (a consortium studying hereditary breast cancer) and the Victorian Cancer Biobank Consortium Committee.
ANZBCTG Annual Report 2012-2013 57 Mr Stephen Porges
Mr Porges was appointed to the ANZBCTG Board of Directors in 2010. He was the Chief Executive Officer at Aussie for almost five years, having spent over 20 years in International Banking and Investment Banking, throughout Asia, Europe and the US. His areas of expertise are finance and strategy. Mr Porges was the Chief Executive Officer at the Newcastle Permanent Building Society and was CEO of listed Biotechnology company Proteome Systems. He is also on the Council of Wesley College, Sydney University, a member of the Dean’s Advisory Board for the Sydney University Business School and a Director of the Australian Business and Community Network. Professor John Simes
Professor John Simes has been an ANZBCTG Board Director since 1991. He is Director of the ANZBCTG Statistical Centre located at the NHMRC Clinical Trials Centre and a member of the ANZBCTG Scientific Advisory Committee. Professor Simes is a Medical Oncologist at the Royal Prince Alfred Hospital Sydney, a Professor of Clinical Epidemiology at the University of Sydney and Director of Sydney Catalyst Translational Cancer Research Centre. He is the founding Director of the NHMRC Clinical Trials Centre (CTC) and is responsible for the CTC’s overall research program.
58 ANZBCTG Annual Report 2012-2013 Scientific Advisory Committee (SAC) (31 March 2013)
Assoc Prof Nicholas Wilcken Medical Oncologist Chair Assoc Prof Prue Francis Medical Oncologist Vice Chair Prof Bruce Mann Surgical Oncologist Chair, SAC Local Therapy Subcommittee Prof Phyllis Butow Psycho-Oncologist Co-Chair, SAC Supportive Care Subcommittee Prof Kelly-Anne Phillips Medical Oncologist Co-Chair, SAC Supportive Care Subcommittee Assoc Prof Nicole McCarthy Medical Oncologist Chair, SAC Systemic Therapy Subcommittee Prof Frances Boyle AM Medical Oncologist Assoc Prof Richard Bell Medical Oncologist Assoc Prof Ian Campbell Surgical Oncologist Assoc Prof Jacquie Chirgwin Medical Oncologist Assoc Prof Boon Chua Radiation Oncologist Prof Alan Coates AM Medical Oncologist Prof John Collins* Surgical Oncologist Prof Joanna Dewar Medical Oncologist Prof John Forbes AM Surgical Oncologist Assoc Prof Glenn Francis Pathologist Prof Val Gebski ANZBCTG Group Statistician Ms Cheryl Grant ANZBCTG Consumer Advisory Panel Prof Michael Green Medical Oncologist Prof David Joseph Radiation Oncologist Dr Ron Kay Surgical Oncologist Dr Belinda Kiely Medical Oncologist Dr Marion Kuper-Hommel Medical Oncologist Prof Geoffrey Lindeman Medical Oncologist / Clinician-Scientist Mrs Dianne Lindsay ANZBCTG Trials Coordination Department Dr Janine Lombard Medical Oncologist Dr Gillian Mitchell Medical Oncologist Adjunct Prof Linda Reaby AM* ANZBCTG Consumer Advisory Panel Assoc Prof Clare Scott Medical Oncologist / Clinician-Scientist Prof R John Simes Medical Oncologist / Statistician Assoc Prof Raymond Snyder Medical Oncologist Dr Craig Underhill** Medical Oncologist Ms Leonie Young ANZBCTG Consumer Advisory Panel
* Retired from the SAC in December 2012 ** Retired from the SAC in January 2013
ANZBCTG Annual Report 2012-2013 59 Independent Data Safety and Monitoring Committee
Prof Martin Tattersall Chair Prof Matthew Law Prof Michael Quinn Assoc Prof Sandra Turner Prof John Zalcberg
Consumer Advisory Panel Members (31 March 2013)
Leonie Young QLD Chair Consumer Coordinator, IMPACT Program Petrina Burnett WA Raewyn Calvert NZ Sheryl Fewster WA Leslie Gilham VIC Cheryl Grant NSW Adjunct Prof Linda Reaby AM ACT Carol Whiteside NSW
Staff Member Listing (1 April 2012 to 31 March 2013)
Heath Badger Team Leader Corinna Beckmore Project Officer – Protocol Development Lauren Boyes Team Leader Julie Callaghan BCIA General Manager Tamar Carpenter BCIA Fundraising Data Manager Anna Cummins BCIA Appeal Coordinator Haley Deacon Trial Coordinator Annette Dempsey Trial Coordinator Cheryl Dodds BCIA Donor Relations Officer Donna Douglass Administration Assistant Breanna Edman BCIA Gift Processing Officer Robyn Ferrie Human Resources Advisor Anna Fitzgerald Communications Manager Akiko Kato-Fong Senior Trials Coordinator Nicole Francis Administration Assistant Sharyn Frank Information Support Officer
60 ANZBCTG Annual Report 2012-2013 Helen Garner Personal Assistant to Professor John Forbes Kellie Gasson Administrative Officer Leigh Hainsworth BCIA Bequest Officer Maria Hartman Trial Coordinator Lynn Hay Senior Trials Coordinator Elizabeth Hutchings Project Officer – Concept Development Juliette Jameson Administration Assistant Angela Johns Project Officer – Ethics and Regulatory Affairs Amy Jongerden Trial Coordinator Ingrid Laycock Senior Trials Coordinator Jenny Leggett BCIA Public Relations Manager Dianne Lindsay Head of Trials Management Mai Ly Trial Coordinator Ashlee Lucas Trial Coordinator Rose Lucas Trial Coordinator Lauren Macnab Senior Trials Coordinator Kelly Martin BCIA Donor Development Manager Tracy McArthur Accounts Administrator Belinda Mitchell Senior Trials Coordinator Rebecca Moder Quality Assurance Officer Sandy Morris BCIA Gift Processing Officer Anthony Morrison Trial Coordinator Sophia Moscovis Senior Trials Coordinator David Mossman Trial Coordinator Alison Newton Trial Coordinator Katie Oleksyn Trial Coordinator Lisa Paksec Ethics and Regulatory Affairs Manager Leonie Phillott Human Resources Advisor David Pringle Financial Controller Flonda Probert Trial Coordinator Stuart Reeves Trial Coordinator Hollie Ritchie Trial Coordinator Kristy Schmidt Project Officer – Ethics and Regulatory Affairs Lisa Sipple Personal Assistant to Chief Operating Officer Soozy Smith Chief Operating Officer Kristy Taubman Trial Coordinator Victoria Tayler BCIA Special Projects Officer Rochelle Thornton Team Leader Katie Vullo Recruitment and Promotions Officer Angie Ward Trial Coordinator Christine Wasik Business Administrator – Accounts Receivable Coralie Watson Trial Coordinator Julianne Webb Trial Coordinator Stacey Wilks Business Administrator – Accounts Payable
ANZBCTG Annual Report 2012-2013 61 Contributors and Supporters
International Collaborators
Breast International Group (BIG) Belgium Breast European Adjuvant Studies Team (BrEAST) Belgium Translational Research in Oncology (TRIO) France Cancer Trials Support Unit (CTSU) USA Clinical Trial Service Unit (CTSU) UK Cancer Research UK (CRUK) UK Eastern Cooperative Oncology Group (ECOG) USA International Breast Cancer Study Group (IBCSG) Switzerland and USA National Institute of Canada, Clinical Trials Group (NCIC-CTG) Canada National Surgical Adjuvant Breast and Bowel Project (NSABP) USA Swiss Group for Clinical Cancer Research (SAKK) Switzerland Southwest Oncology Group (SWOG) USA
Participating Institutions
Australian Capital Territory
Metropolitan The Canberra Hospital Garran – Canberra
New South Wales
Metropolitan Bankstown-Lidcombe Hospital Bankstown – Sydney The Breast & Endocrine Centre Gateshead – Newcastle Calvary Mater Newcastle Waratah – Newcastle Concord Repatriation General Hospital Concord – Sydney Lingard Private Hospital Merewether – Newcastle Newcastle Private Hospital New Lambton Heights – Newcastle Liverpool Hospital Liverpool – Sydney Macarthur Cancer Therapy Centre Campbelltown – Sydney Mater Hospital North Sydney – Sydney Nepean Cancer Care Centre Kingswood – Sydney Prince of Wales Hospital Randwick – Sydney Royal Hospital for Women Randwick – Sydney
62 ANZBCTG Annual Report 2012-2013 Royal North Shore Hospital St Leonards – Sydney Royal Prince Alfred Hospital Camperdown – Sydney St George Hospital Kogarah – Sydney St Vincent’s Hospital Darlinghurst – Sydney Sydney Haematology & Oncology Clinic Wahroonga – Sydney Westmead Hospital Westmead - Sydney Regional Armidale Hospital Armidale Coffs Harbour Health Campus Coffs Harbour Lismore Base Hospital Lismore Manning Rural Referral Hospital Taree Port Macquarie Base Hospital Port Macquarie Riverina Cancer Care Centre Wagga Wagga Southern Highlands Cancer Centre Bowral Tamworth Rural Referral Hospital Tamworth The Tweed Hospital Tweed Heads Wollongong Hospital Wollongong
Queensland
Metropolitan HOCA @ Wesley Auchenflower – Brisbane HOCA Chermside Chermside – Brisbane Mater Adult Hospital South Brisbane – Brisbane Princess Alexandra Hospital Woolloongabba – Brisbane Royal Brisbane and Women’s Hospital Herston – Brisbane The Wesley Breast Clinic Auchenflower – Brisbane Regional Cairns Base Hospital Cairns Nambour Hospital Nambour St Andrew’s Toowoomba Hospital Toowoomba Toowoomba Hospital Toowoomba Townsville Hospital Townsville
South Australia
Metropolitan Ashford Cancer Centre Ashford – Adelaide Flinders Medical Centre Bedford Park – Adelaide The Queen Elizabeth Hospital Woodville South – Adelaide Royal Adelaide Hospital Adelaide St Andrew’s Medical Centre Adelaide
ANZBCTG Annual Report 2012-2013 63 Tasmania
Metropolitan Royal Hobart Hospital Hobart Regional North West Regional Hospital Burnie Launceston General Hospital Launceston Mersey Community Hospital Latrobe
Victoria
Metropolitan The Alfred Hospital Prahran – Melbourne Austin Health Heidelberg – Melbourne Box Hill Hospital Box Hill – Melbourne Cabrini Hospital Malvern – Melbourne Epworth Richmond Hospital Richmond – Melbourne Maroondah Hospital Maroondah – Melbourne Monash Breast Clinic Clayton – Melbourne Monash Medical Centre East Bentleigh – Melbourne The Northern Hospital Epping – Melbourne Peter MacCallum Cancer Centre East Melbourne – Melbourne The Royal Melbourne Hospital Parkville – Melbourne St Vincent’s Hospital Fitzroy – Melbourne Victorian Breast & Oncology Care East Melbourne – Melbourne Western Hospital Footscray – Melbourne
Regional Ballarat Health Services Ballarat Ballarat Oncology and Haematology Services Wendouree The Bendigo Hospital Bendigo Border Medical Oncology Wodonga Frankston Hospital Frankston Frankston Private Frankston The Geelong Hospital Geelong Goulburn Valley Health Shepparton St John of God Hospital Geelong
Western Australia
Metropolitan Mount Hospital Perth Royal Perth Hospital Perth St John of God Hospital Subiaco – Perth Sir Charles Gairdner Hospital Nedlands – Perth
Regional St John of God Hospital Bunbury
64 ANZBCTG Annual Report 2012-2013 New Zealand
Metropolitan Auckland City Hospital Auckland North Shore Hospital Auckland Wellington Hospital Wellington South – Wellington
Regional Christchurch Hospital Christchurch Dunedin Hospital Dunedin Palmerston North Hospital Palmerston North Waikato Hospital Hamilton
Funders and Supporters
Breast Cancer Research Foundation, USA Cancer Australia Cancer Institute NSW Hunter Medical Research Institute National Breast Cancer Foundation National Health and Medical Research Council NSW Department of Health University of Newcastle
Sponsors
Corporate Sponsors
The Cartridge Recycler
ANZBCTG Annual Report 2012-2013 65 Financial Report
The ANZBCTG is in a strong financial position to continue its research program and to fund its commitment to existing trials, many of which will require funding well into the future.
The ANZBCTG is a not for profit, collaborative, national and international breast cancer clinical trials research group. It is an independent registered company with academic affiliations.
The ANZBCTG is governed by a Board of Directors and the terms of its Constitution. The Board of Directors has a Finance and Audit Subcommittee (FAC) to assist with its financial oversight responsibilities. This Board Subcommittee has a Terms of Reference and meets four times per year.
Financial management of the ANZBCTG has two main facets:
• management of ANZBCTG finances and resources (financial year – 1 April to 31 March); • management of competitive and other grant funds administered by other Institutions.
Each year the ANZBCTG undergoes independent financial audit to ensure its compliance with all applicable company, taxation, charitable and financial legislation and regulation. The ANZBCTG’s independent auditor is rotated every five years and the current company auditor will provide audit services until the end of the 2013/2014 financial year. Financial Management of the ANZBCTG
Because of its company status, the majority of the ANZBCTG’s income is managed directly by the Group. The Chief Operating Officer undertakes day to day financial management according to the delegations vested in this position by the Board, and ensures the ANZBCTG adheres to applicable Australian corporate, taxation and charity legislation.
Sources of ANZBCTG income:
• clinical trials research program (pharmaceutical partnerships, international collaborative group partnerships, untied education grants); • competitive grants awarded to the ANZBCTG (Cancer Australia); • fundraising activities (donations, special events, corporate support, bequests); • earnings from invested funds;
66 ANZBCTG Annual Report 2012-2013 • other income (Annual Scientific Meeting registration fees and sponsorship, and sundry items).
Areas of ANZBCTG expenditure:
• clinical trials research program (clinical trials development, activation, coordination and quality assurance activities; funding for participating institutions, randomisation and statistical analyses; staff member salaries, Annual Scientific Meeting and other meetings); • fundraising and administration; • other recurrent monthly infrastructure costs, staff member salaries and core business expenses. Financial Management of Competitive Grant Funds Administered by other Institutions
The ANZBCTG applies for and secures competitive grants. Competitive grant funding mechanisms include streams for both research and infrastructure funding, and can be sourced from many organisations including but not limited to:
• National Health and Medical Research Council (NHMRC) (government); • Cancer Institutions NSW (government); • Cancer Councils (government/private); • National Breast Cancer Foundation (private); • Other Trusts and Foundations.
Competitive grant funds are administered by a recognised ‘administering institution’ and it is the responsibility of the administering institution to financially and legally account for the grants it administers. The University of Newcastle is the ANZBCTG’s usual administering institution and competitive grant funding administered by this or other institutions is not shown in the financial statements of the ANZBCTG.
The Group’s competitive grant receipts amounted to just under $1 million for the reporting period, the most significant being two project grants from the NHMRC for the IBIS-II and LATER clinical trials. Financial Results for the year ended March 2013
For the year ended March 2013, the ANZBCTG reported a net income of $2.603 million, which is a $2.303 million improvement over the result for the previous year. This improvement was a combination of increased revenue from sources such as bequests, income on invested funds and grants; and cost savings in labour, computer development and trial administration. During the year the net assets of the ANZBCTG increased from $16.768 million to $19.370 million.
The ANZBCTG is in a strong financial position to continue its research program and to fund its commitment to existing trials, many of which will require funding well into the future.
David Pringle Financial Controller
ANZBCTG Annual Report 2012-2013 67 Financial Statements
The statements contained in this Financial Report are a summary of the independently audited accounts for the financial year ended 31 March 2013. In some cases data for the year ended March 2012 has been restated to be comparable with the format used for reporting this year.
Full audited financial statements are available by contacting the ANZBCTG. Any ANZBCTG surplus is committed to supporting current and future ANZBCTG research projects. All ANZBCTG payroll liabilities are annually expensed to the external suppliers which manage the ANZBCTG’s payroll.
Income and Expenditure Statement
2013 2012 $ $
INCOME Clinical trials research program 2,869,731 2,989,502 Fundraising activities 5,571,708 4,845,917 Earnings from invested funds 1,056,560 709,889 Other Income 1,314,874 1,301,916
TOTAL INCOME 10,812,873 9,854,224
EXPENDITURE Clinical trials research program 4,667,459 5,383,233 Fundraising and administration 1,313,023 1,205,469 Administration support for the clinical 2,229,784 2,966,160 trials research program
TOTAL EXPENDITURE 8,210,266 9,554,862
NET INCOME 2,602,607 299,362
Analysis of Income and Expenditure
Income Expenditure
Clinical Trials Clinical Trials Research Program Research Program
Fundraising Fundraising and Activities Administration
Earnings from Administration Invested funds Support for the Clinical Trials Other Research Program Income
68 ANZBCTG Annual Report 2012-2013 Statement of Financial Position
2013 2012 $ $ ASSETS
CURRENT ASSETS
Cash and cash equivalents 7,141,530 7,774,556
Trade and other receivables 1,951,001 1,828,100
Other financial assets 7,016,436 4,306,877
Other assets 422,199 1,052,641
Total current assets 16,531,166 14,962,174
NON-CURRENT ASSETS
Property, plant and equipment 648,878 364,462
Other financial assets 4,481,036 4,005,444
Other assets 82,839 110,851
Total non-current assets 5,212,753 4,480,757
TOTAL ASSETS 21,743,919 19,442,931
LIABILITIES CURRENT LIABILITIES
Trade and other payables 961,302 1,245,853
Other financial liabilities 1,412,276 1,429,343
Total current liabilities 2,373,578 2,675,196
TOTAL LIABILITIES 2,373,578 2,675,196
NET ASSETS 19,370,341 16,767,735
EQUITY
Retained earnings 19,370,341 16,767,735
TOTAL EQUITY 19,370,341 16,767,735
ANZBCTG Annual Report 2012-2013 69 Publications
01/04/2012 to 31/12/2012 857. Bernhard J, Butow P, Aldridge J, Juraskova I, Ribi K, Brown R. Communication about standard treatment options and clinical trials: can we teach doctors new skills to improve patient outcomes? Psycho-Oncology 2012;21(12):1265-1274. 858. Coates AS, Colleoni M, Goldhirsch A. Is adjuvant chemotherapy useful for women with Luminal A breast cancer? J Clin Oncol. 2012;30(12):1260-1263. 859. Coates AS, Millar EKA, O’Toole SA, Molloy TJ, Viale G, Goldhirsch A, Regan MM, Gelber RD, Sun Z, Castiglione-Gertsch M, Gusterson B, Musgrove EA, Sutherland RL. Prognostic interaction between expression of p53 and estrogen receptor in patients with node-negative breast cancer: results from IBCSG Trials VIII and IX. Breast Cancer Res. 2012;14(6):R143. 860. Dellapasqua S, Bagnardi V, Regan MM, Rotmensz N, Mastropasqua MG, Viale G, Maiorano E, Price KN, Gelber RD, Castiglione-Gertsch M, Goldhirsch A, Colleoni M. A risk score based on histopathological features predicts higher risk of distant recurrence in premenopausal patients with lymph node-negative endocrine-responsive breast cancer. Breast. 2012;21(5):621-628. 861. Ewertz M, Gray KP, Regan MM, Ejlertsen B, Price KN, Thürlimann B, Bonnefoi H, Forbes JF, Paridaens RJ, Rabaglio M, Gelber RD, Colleoni M, Láng I, Smith IE, Coates AS, Goldhirsch A, Mouridsen HT. Obesity and risk of recurrence or death after adjuvant endocrine therapy with letrozole or tamoxifen in the Breast International Group 1-98 trial. J Clin Oncol. 2012;30(32):3967-3975. 862. Fernández-Cuesta L, Oakman C, Falagan-Lotsch P, Smoth K, Quinaux E, Buyse M, Dolci MS, De Azambuja E, Hainaut P, Dell’Orto P, Larsimont D, Francis PA, Crown J, Piccart-Gebhart M, Viale G, Di Leo A, Olivier M. Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline or anthracycline/taxane-based adjuvant therapy: results from the BIG 02-98 phase III trial. Breast Cancer Res. 2012;14(3):R70. 863. Huober J, Gelber S, Goldhirsch A, Coates AS, Viale G, Öhlschlegel C, Price KN, Gelber RD, Regan MM, Thürlimann B. Prognosis of medullary breast cancer: analysis of 13 International Breast Cancer Study Group (IBCSG) trials. Ann Oncol. 2012;23(11):2843-2851. 864. Karlsson P, Cole BF, Chua BH, Price KN, Lindtner J, Collins JP, Kovács A, Thürlimann B, Crivellari D, Castiglione-Gertsch M, Forbes JF, Gelber RD, Goldhirsch A, Gruber G. Patterns and risk factors for locoregional failures after mastectomy for breast cancer: an International Breast Cancer Study Group report. Ann Oncol. 2012;23(11):2852-2858. 865. Millar EKA, Coates AS, O’Toole S, Selinger C, Musgrove EA, Yan M, Viale G, Regan MM, Price KN, Sun Z, Castiglione MM, Colleoni M, Gelber RD, Goldhirsch A, Sutherland RL. Intrinsic subtype and its clinical significance in early node-negative breast cancer: Results from two randomized trials of adjuvant chemoendocrine therapy. J Clin Oncol. 2012;30(Suppl.):Abstract 504. 866. Phillips K-A, Kiely BE, Francis PA, Boyle FM, Fox SB, Murphy L, Gebski V, Lindsay DF, Sutherland RL, Badger HD, Forbes JF. ANZ1001 SORBET: Study of oestrogen receptor beta and efficacy of tamoxifen, a single arm, phase II study of the efficacy of tamoxifen in triple-negative but estrogen receptor beta-positive metastatic breast cancer. J Clin Oncol. 2012;30(Suppl.):Abstract TPS1136. 867. Phillips KA, Ribi K, Aldridge J, Thompson AM, Harvey VJ, Thürlimann BJ, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J, for the International Breast Cancer Study Group and BIG 1-98 Collaborative Group. Subjective cognitive complaints one year after ceasing adjuvant endocrine therapy for early stage breast cancer: Findings from the Breast International Group (BIG) 1-98 Trial. J Clin Oncol. 2012;30(Suppl.):Abstract 9022.
70 ANZBCTG Annual Report 2012-2013 868. Regan MM, Leyland-Jones B, Bouzyk M, Pagani O, Tang W, Kammler R, Dell’Orto P, Biasi MO, Thürlimann B, Lyng MB, Ditzel HJ, Neven P, Debled M, Maibach R, Price KN, Gelber RD, Coates AS, Goldhirsch A, Rae JM, Viale G; on behalf of the Breast International Group (BIG) 1-98 Collaborative Group. CYP2D6 genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: The Breast International Group 1-98 Trial. J Natl Cancer Inst. 2012;104(6):441-451. 869. Ribi k, Aldridge J, Phillips K-A, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J and for the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group (IBCSG). Subjective cognitive complaints one year after ceasing adjuvant endocrine therapy for early-stage breast cancer. Br J Cancer. 2012;106(10):1618-1625. 870. Sestak I, Harvie M, Howell A, Forbes JF, Dowsett M, Cuzick J. Weight change associated with anastrozole and tamoxifen treatment in postmenopausal women with or at high risk of developing breast cancer. Breast Cancer Res Treat. 2012;134(2):727-734. 871. Zaman K, Thürlimann B, Huober J, Schönenberger A, Pagani O, Lüthi J, Simcock M, Giobbie-Hurder A, Berthod G, Genton C, Brauchli P, Aebi S; on behalf of the Swiss Group for Clinical Cancer Research (SAKK). Bone mineral density in breast cancer patients treated with adjuvant letrozole, tamoxifen, or sequences of letrozole and tamoxifen in the BIG 1-98 study (SAKK 21/07). Ann Oncol. 2012;23(6):1474-1481.
01/01/2013 to 31/03/2013 872. Bernhard J, Aldridge J, Butow PN, Zoller P, Brown R, Smith A, Juraskova I. Patient-doctor agreement on recall of clinical trial discussion across cultures. Ann Oncol. 2013;24(2):391-397. 873. Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, Abraham M, Alencar VHM, Badran A, Bonfill X, Bradbury J, Clarke M, Collins R, Davis SR, Delmestri A, Forbes JF, Haddad P, Hou M-F, Inbar M, Khaled H, Keilanowska J, Kwan W-H, Mathew BS, Mittra I, Müller B, Nicolucci A, Peralta O, Pernas F, Petruzelka L, Pienkowski T, Radhika R, Rajan B, Rubach MT, Tort S, Urrútia G, Valentini M, Wang Y, Peto R, for the ATLAS Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805-816. 874. Loi S, Sirtaine N, Piette F, Salgado R, Viale G, Van Eenoo F, Rouas G, Francis P, Crown JPA, Hitre E, de Azambuja E, Quinaux E, Di Leo A, Michiels S, Piccart MJ, Sotiriou C. Prognostic and predictive value of tumor-infiltrating lymphocytes in a phase III randomized adjuvant breast cancer trial in node-positive breast cancer comparing the addition of docetaxel to doxorubicin with doxorubicin- based chemotherapy: BIG 02-98. J Clin Oncol. 2013;31(7):860-867. 875. Metzger-Filho O, de Azambuja E, Bradbury I, Saini KS, Bines J, Simon SD, Van Dooren V, Aktan G, Pritchard KI, Wolff AC, Smith I, Jackisch C, Lang I, Untch M, Boyle F, Xu B, Baselga J, Perez EA, Piccart-Gebhart M. Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: the adjuvant lapatinib and/or trastuzumab treatment optimization experience. Oncologist. 2013;18:134-140. 876. Oakman C, Francis PA, Crown J, Quinaux E, Buyse M, De Azambuja E, Margeli Vila M, Andersson M, Nordenskjöld B, Jakesz R, Thürlimann B, Gutiérrez J, Harvey V, Punzalan L, Dell’Orto P, Larsimont D, Steinberg I, Gelber RD, Piccart-Gebhart M, Viale G, Di Leo A. Overall survival benefit for sequential doxorubicin-docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer—8-year results of the Breast International Group 02-98 phase III trial. Ann Oncol. 2013; 4 January:E-Pub. 877. Pestalozzi BC, Holmes E, de Azambuja E, Metzger-Filho O, Hogge L, Scullion M, Láng I, Wardley A, Lichinitser M, Lopez Sanchez RI, Müller V, Dodwell D, Gelber RD, Piccart-Gebhart MJ, Cameron D. CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01). Lancet Oncol. 2013;14(3):244-248.
ANZBCTG Annual Report 2012-2013 71 Glossary of Terms
ACCRUAL TARGET (RECRUITMENT TARGET): The number of participants planned to be enrolled in the trial.
ADJUVANT THERAPY: Additional treatment used to improve the effects of surgical treatment. In cancer, adjuvant therapy may include chemotherapy, hormonal or radiation therapy after surgery, which is aimed at killing any remaining cancer cells.
ADJUVANT! ONLINE: An internet-based computer program to assist health professionals and patients to discuss the risks and benefits of additional therapy options after breast cancer surgery.
ADVANCED BREAST CANCER: Cancer that has spread from the original site in the breast (metastasised) to other organs or tissues in the body. Also known as secondary breast cancer or metastatic breast cancer.
ANGIOGENIC: Blood vessel formation, which usually accompanies the growth of malignant tissue.
ANTIANGIOGENIC MOLECULE: An orally delivered small-molecule formulation with antiangiogenic and anticancer activity.
AROMATASE INHIBITORS (AI) (examples: anastrozole, exemestane and letrozole): A class of drugs used in the treatment of breast cancer in postmenopausal women. Some cancers require oestrogen to grow. Aromatase is an enzyme that synthesises oestrogen. Aromatase inhibitors block the synthesis of oestrogen. This lowers the oestrogen level, and slows the growth of cancers.
AXILLA: The underarm or armpit.
AXILLARY DISSECTION: Surgery to remove lymph nodes from the armpit. The procedure can be performed either at the same time as breast surgery or as a separate operation.
AXILLARY LYMPH NODES: Lymph nodes in and near the armpit.
BIOPSY: The removal of a small sample of tissue or cells from the body to help diagnose a disease.
BREAST CONSERVING SURGERY: Surgery to remove part of the breast. Also called a lumpectomy or a wide local excision.
CHEMOTHERAPY (examples: cyclophosphamide, doxorubicin, docetaxel and capecitabine): The use of medications (drugs) that are toxic to cancer cells. These drugs kill the cells, or prevent or slow their growth. The standardised combination of such drugs in the treatment of cancer is referred to as a ‘treatment regimen’.
CLINICAL TRIAL: Research conducted with the participant’s consent which usually involves a comparison of two or more treatments or diagnostic methods. Clinical trials are conducted to gain a better understanding of the underlying disease process and/or methods to treat or prevent it. The clinical trial process includes Phase I, II, and III trials.
DIMERISATION INHIBITOR: An antibody that prevents a compound or unit being produced by the combination of two like molecules.
DOUBLE-BLIND TRIAL: A clinical trial in which neither the participating individual nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or another therapy.
DUCTAL CARCINOMA IN SITU (DCIS): Abnormal cells in the breast ducts, which over time could develop into invasive breast cancer.
EARLY (Primary) BREAST CANCER: Breast cancer that has not spread beyond the breast or the axillary lymph nodes. This includes ductal carcinoma in situ and stage I, IIA, IIB, and IIIA breast cancers.
ELIGIBILITY CRITERIA: Participant eligibility criteria for clinical trials can range from general (age, type of cancer) to specific (prior treatment, tumour characteristics, blood cell counts, organ function). Eligibility criteria may also vary with the stage of the disease.
72 ANZBCTG Annual Report 2012-2013 ENDOCRINE-RESPONSIVE: Another name for hormone-responsive, or hormone receptor-positive breast cancer. Refer also to “hormone (endocrine) treatment”.
GOOD CLINICAL PRACTICE (GCP): An international standard for the design, conduct, performance, recording and reporting of clinical trials; that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
GRADE (TUMOUR GRADE): The degree of similarity of the cancer cells to normal cells. Grade is assessed by a pathologist. Grade 1 carcinoma is well differentiated and is associated with a better prognosis. Grade 2 carcinoma is moderately differentiated and is associated with an intermediate prognosis. Grade 3 carcinoma is poorly differentiated and is generally associated with a worse prognosis.
HER2-POSITIVE (HER2-amplified):HER2 stands for Human Epidermal Growth Factor Receptor 2. In HER2-positive breast cancer, the cancer cells have an abnormally high number of HER2 genes per cell. When this happens, too much HER2 protein appears on the surface of these cancer cells. This is called HER2 protein over expression or amplified. Too much HER2 protein is thought to cause cancer cells to grow and divide more quickly.
HER SIGNALLING PATHWAYS: One of the many complex processes associated with cell communication and action. The role of specific molecules in a cell which, via a cascade effect, inhibit or allow particular cell functions. Drugs being developed to inhibit these pathways might lead to new ways to block cancer cell growth and kill cancer cells.
HORMONE (ENDOCRINE) TREATMENT: Hormone (endocrine) treatment is used to treat breast cancers that are hormone receptor-positive, also known as hormone-responsive or endocrine-responsive. These cancers have receptors for the hormones oestrogen and/or progesterone; they are called ER and/or PR-positive cancers. There are several different types of hormone treatments. Some are taken as tablets (tamoxifen or aromatase inhibitors) and some are treatments to turn off or remove the ovaries (injections, surgery and sometimes radiotherapy).
HORMONE RECEPTORS: Proteins in a cell which bind to specific hormones. This stimulates the cell to act in a particular way.
HORMONE REPLACEMENT THERAPY (HRT): Drug therapy that supplies the body with hormones that it is no longer able to produce; usually to relieve menopausal symptoms.
HORMONE-RESPONSIVE: Also known as hormone receptor-positive or endocrine-responsive breast cancer.
HUMAN RESEARCH ETHICS COMMITTEE (HREC): The Human Research Ethics Committee’s function is to review proposed research in order to ensure that the subject’s rights are protected and that risk of harm is minimised.
HYPOTHESIS: Provides a suggested solution based on evidence.
IMMUNOHISTOCHEMISTRY (or IHC): Used to identify tissue components (e.g. abnormal cells in a cancerous tumour, different parts of biological tissue) by using a marker such as a fluorescent dye or an enzyme. The marker is attached to a type of protein (antigen) that finds another type of protein (antibody) and reacts to colour the target cells.
INDEPENDENT DATA SAFETY AND MONITORING COMMITTEE (IDSMC): An independent group of experts or adequately qualified individuals who monitor participant safety and treatment effectiveness data while a clinical trial is ongoing.
INFORMED CONSENT: Informed consent is a process whereby a person gives consent based on a clear understanding of the facts, any implications and possible future consequences. In the case of a clinical trial, these facts, implications and consequences are conveyed in the Participant Information Sheet and any associated materials.
IPSILATERAL: On or affecting the same side of the body.
Isoform: Any of two or more functionally similar proteins that may have a similar but not identical amino acid sequence, for example, there are two known isoforms of the oestrogen receptor, alpha (α) and beta (β).
LOCALLY ADVANCED BREAST CANCER: Breast cancer that has one or more of the following features: may be large (typically bigger than 5 cm); may have spread to several lymph nodes in the armpit (axilla) or other areas near the breast; and may have spread to other tissues around the breast such as the skin, muscle or ribs.
LUMPECTOMY: Also called “Breast Conserving Surgery”.
LYMPHOEDEMA: Swelling caused by a build-up of lymph fluid, as a result of lymph nodes being removed or not working properly.
ANZBCTG Annual Report 2012-2013 73 MAGNETIC RESONANCE IMAGING (MRI): A medical imaging device using a strong magnetic field and radio frequency to produce detailed images of internal body parts and structures. MRI is especially useful for imaging soft tissue like the brain, heart, muscles and tumours.
MAMMOGRAM: An x-ray of the breast.
MASTECTOMY: The surgical removal of the whole breast.
METASTATIC BREAST CANCER: Cancer that has spread from the original site in the breast to other organs or tissues in the body. Also known as secondary breast cancer or advanced breast cancer.
MICROMETASTASES: Small cancer cells that have spread (metastases) beyond the primary tumour and can only be detected by microscopic evaluation.
MONOCLONAL ANTIBODIES (examples: trastuzumab and bevacizumab): A treatment designed to specifically target a cell within the body, particularly cancer cells. Different cancer types can be targeted with different monoclonal antibodies.
MORBIDITY: The relative incidence of a particular disease within a defined population.
NEOADJUVANT: Treatment given prior to surgery or further treatment for cancer.
NODAL STATUS: Whether a breast cancer has spread (node-positive) or has not spread (node-negative) to lymph nodes in the armpit (axillary nodes). The number and site of positive axillary nodes can help predict the risk of cancer recurrence.
OESTROGEN: The main female sex hormone produced mostly by the ovaries.
OESTROGEN RECEPTOR (ER): A protein that may be present on certain cells to which oestrogen molecules can attach. The term “ER-positive” refers to tumour cells that contain the oestrogen-receptor protein. These cells are generally sensitive to hormone therapy.
OESTROGEN RECEPTOR ALPHA (ERα): One of two specific Oestrogen Receptor (ER) proteins. In standard clinical practice ERα is the primary ER protein assessed when determining if a tumour is “ER-positive”.
OESTROGEN RECEPTOR BETA (ERβ): One of two specific Oestrogen Receptor (ER) proteins. ERβ is the less common variation of the ER protein and is not routinely assessed in standard clinical practice.
ONCOLOGIST: A doctor who specialises in treating cancer.
ONCOLOGY: A branch of medicine that deals with cancer.
OOPHORECTOMY: The surgical removal of an ovary or ovaries.
OPEN-LABEL TRIAL: A clinical trial in which doctors and participants know which drug or treatment is being administered.
OSTEOPOROSIS: A disease characterised by low bone mass and deterioration of bone architecture, which increases the susceptibility to fractures.
PARTICIPANT INFORMATION SHEET: A document designed to provide participants with relevant information and facts relating to the proposed clinical trial in order for the participant to make an informed decision regarding their participation in the trial.
PARTICIPATING INSTITUTION: Any public or private hospital or facility where ANZBCTG clinical trials are conducted.
PHASE II CLINICAL TRIAL: The second stage of the evaluation of a new drug in humans; these trials evaluate drug safety and preliminary efficacy (effectiveness) in a large number of participants (up to several hundred).
PHASE III CLINICAL TRIAL: The most rigorous and extensive type of scientific clinical investigation of a new treatment. These trials are designed to determine the effectiveness of a treatment, often by comparing it to an existing standard therapy or a placebo, in a large number of participants (typically hundreds or thousands). A phase III trial is generally required before a drug would be approved by regulatory authorities for general use.
PLACEBO: An inert tablet (such as a sugar pill), liquid or powder that has no active ingredient. In clinical trials, experimental treatments are often compared with a placebo to assess the treatment’s effectiveness.
74 ANZBCTG Annual Report 2012-2013 PREDICTIVE FACTOR: A finding which assists a clinician to assess whether an individual’s cancer will respond either positively or negatively to a particular treatment. For example, the presence of oestrogen receptors predicts for response to hormone treatment. This term is often confused with “prognostic factor”.
PREVENTION TRIAL: A trial aiming to find better ways to prevent breast cancer in healthy women.
PRINCIPAL INVESTIGATOR (PI): The person responsible for overseeing all aspects of a clinical trial at an ANZBCTG participating institution; recruiting participants; obtaining informed consent; and collecting data.
PROGESTERONE RECEPTOR (PR): A protein that may be present on certain cells to which progesterone molecules can attach. The term “PR-positive” refers to tumour cells that contain the progesterone-receptor protein. These cells are generally sensitive to hormone therapy.
PROGNOSTIC FACTORS: The combination of a number of aspects of a person’s general condition and disease diagnosis. General factors can include, but are not limited to, age, gender, lifestyle and medical history. Specific disease related factors can include disease diagnosis, stage, tumour size and location and treatment options. The combination of these factors can result in either a favourable or poor prognosis.
PROTOCOL: A written, detailed action plan for a clinical trial. The protocol provides the background, specifies the objectives, and describes the design and organisation of the trial.
QUALITY OF LIFE: An individual’s overall appraisal of their situation and subjective sense of well-being.
RADIOTHERAPY: The use of radiation, usually x-rays or gamma rays, to kill cancer cells or damage them so they cannot grow and multiply.
RANDOMISATION: A method of preventing bias in research by ‘randomly’ assigning clinical trial participants to treatment groups. Randomisation ensures each treatment group has a similar range and number of participants, such that any differences between treatment groups at the end of the trial can be attributed to the trial treatments.
RANDOMISED TRIAL: A study in which participants are randomly assigned to one of two or more treatment arms of a clinical trial.
RECURRENCE: The return of breast cancer after a period of remission. During a recurrence, breast cancer cells which have evaded treatment may reappear at the original site or in another part of the body.
RECURRENCE SCORE: Obtained by the Oncotype DX® Assay, is a numerical value between 0-100 representing the likelihood of recurrence to distant parts of the body at 10 years post diagnosis.
SELECTIVE ESTROGEN RECEPTOR MODULATOR (SERM) (examples: tamoxifen and raloxifen): A class of medication that acts on the oestrogen receptors of cells by blocking the effects of naturally produced oestrogen within the body. This form of treatment has been shown to be effective in hormone-sensitive breast cancers.
SENTINEL NODE: The hypothetical first lymph node or group of nodes reached by metastasising cancer cells from a primary tumour.
SENTINEL NODE BIOPSY: Sampling of the sentinel lymph node into which the primary tumour is draining first to determine if a full lymph node exploration is needed.
SIDE EFFECTS: Unwanted effects of a drug or treatment (e.g. nausea, headache, hair loss, etc). Side effects may be short or long term, ranging from minor inconveniences to serious adverse events.
STANDARD TREATMENT (THERAPY): The current best treatment known for a particular disease or condition.
STUDY CHAIR: An adequately qualified clinician assigned by the ANZBCTG to provide clinical advice and guidance for the development and ongoing conduct of a clinical trial.
STUDY COORDINATOR: A member of the research team at an ANZBCTG participating institution who takes responsibility for non-clinical aspects associated with the conduct of a clinical trial.
SUPRA-CLAVICULAR FOSSA: An indentation (fossa) immediately above the clavicle, or collar bone.
SYSTEMIC THERAPY: The use of chemotherapy, hormone therapy and/or targeted therapy or a combination of these to target the entire body to destroy any cancer cells that may have spread to distant body parts but are below the level of clinical detection.
ANZBCTG Annual Report 2012-2013 75 TOXICITY: Harmful side effects from an agent being tested.
TREATMENT TRIALS: Treatment trials are designed to test the safety and effectiveness of new drugs, biological agents, techniques, or other interventions in people who have been diagnosed with cancer. These trials evaluate the new treatment against standard treatment, if there is one.
TRIPLE-NEGATIVE METASTATIC BREAST CANCER (TNBC): ‘Triple-negative’ is the term given to tumours which do not possess Oestrogen Receptor (ER) and Progesterone Receptor (PgR) proteins, and which do not over express the HER2 protein.
TYROSINE KINASE INHIBITOR (example: lapatinib): A drug that interferes with cell communication and growth and which may prevent tumour growth.
76 ANZBCTG Annual Report 2012-2013 ANZBCTG Annual Report
Research for a world without breast cancer. Annual Report 1 April 2012 - 31 March 2013 1 April 2012 - 31 Mar ch 2013
The Australia and New Zealand Breast Cancer Trials Group is supported by its fundraising department the Breast Cancer Institute of Australia.