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Breast Studies Adult Cancer Clinical Research Fast Facts – March 2021 BREAST STUDIES Clinical Research Department: 407-303-2090 Research Coordinators Ingrid Acker, RN (407-303-4471) Alejandra Ricaurte RN (407-303-7346) [email protected] [email protected] Ashley Young (407-303-7162) Lillie Danzy (407-303-2090) [email protected] [email protected] Ext00000206: A Prospective Registry Study to Evaluate the Effect Ext00000206 of the DCISionRT™ Test on Treatment Decisions in Patients with ▪ DCIS Following Breast Conserving Therapy Diagnostic Registry DCIS ▪ Patient must be planning to undergo breast conserving surgery and eligible to receive radiation and/or systemic treatment ▪ Patient must have been diagnosed with DCIS within 120 days of consent ▪ Patient must be greater than 25 years old Target Accrual: 24 ▪ Exclusion: evidence of invasive breast cancer, including Actual Accrual: 20 microinvasion, lymph node involvement, or Paget’s disease of the nipple or suspicious mammogram findings in the lymph nodes or Orlando/Altamonte contralateral breast EA1181 (CompassHER2-pCR): Preoperative THP and EA1181 postoperative HP in patients who achieve a pathologic complete ▪ response NeoAdjuvant Part 1 Component of: Her2 Positive The CompassHER2 Trials (COMprehensive use of Pathologic response ASSessment to optimize therapy in HER2-positive breast cancer) ▪ Must be HER2+, ER and PR can be positive or negative Target Accrual: 12 Actual Accrual: 0 ▪ Clinical Stage II and IIIa (T2-3/N0-2/M0): (cN0) are eligible if T size is > 2.0, (cN1-2) are eligible if T size is > 1.5. ▪ No prior hx of ipsilateral or contralateral invasive cancer: EXECPT Hx of T1N0 triple negative breast cancer diagnosed 10 years earlier are eligible ▪ No prior treatment for current breast cancer Exclusion: T4 and/or N3 disease Orlando/Altamonte A Randomized Phase III Trial Comparing Axillary Lymph Node Registration Step 2 (Confirmation of Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 Evaluability) will be temporarily Adult Cancer Clinical Research Fast Facts – March 2021 unavailable for new registrations, N1) Who Have Positive Sentinel Lymph Node Disease After effective 09/01/2020 Neoadjuvant Chemotherapy. ALLIANCE A011202 ▪ Must Have ER, PR and HER2 status (by IHC and/or ISH) on ▪ diagnostic core biopsy prior to neoadjuvant therapy Status Post Neoadjuvant Chemotherapy ▪ Clinical Stage T1-N1 M0 breast cancer at Dx prior to start ▪ neoadjuvant chemotherapy Radiation ▪ Must have clinically negative axilla on physical examination at completion of neoadjuvant therapy Target Accrual: 3 Actual Accrual:0 ▪ At least 4 cycles of neoadjuvant therapy prior to surgery ▪ Exclusion: Sandwich Chemo; neoadjuvant endocrine or radiation Orlando/Altamonte SGNLVA-002 Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in ▪ Combination with Pembrolizumab for First-Line Treatment of Triple Negative 1st Line Patients with Unresectable Locally-Advanced or Metastatic ▪ Triple-Negative Breast Cancer Unresectable Locally Advanced or Metastatic ▪ Participating in Part C Dose Level 1 On Hold Orlando A Phase III Randomized Trial of Hypofractionated Post ALLIANCE A221505 Mastectomy Radiation with Breast Reconstruction ▪ Post Mastectomy Radiation ▪ Stage IIa-IIIa; ECOG PS 0-1 ▪ No prior radiation therapies Target Accrual: 5 Actual Accrual:23 ▪ Patients must be able to read and comprehend English Orlando/Altamonte/Celebration S1418: A Randomized, Phase III Trial to Evaluate the Efficacy and S1418 Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for ▪ Triple Receptor-Negative Breast Cancer with >/= 1 CM Residual Adjuvant Invasive Cancer or Positive Lymph Nodes (ypN+) after Residual TNBC Neoadjuvant Chemotherapy S1418 BAHO Substudy ▪ ER, PR and HER2 negative, as well as ER and PR <= 5% (BR006) is Temporarily positive or HER2 equivocal, breast cancers by ASCO/CAP closed to accrual, effective guidelines with > 1 cm residual invasive cancer in the breast, June 23, 2020. or any invasive tumor in the lymph nodes, including N1 mic, after completion of 16-24 weeks of neoadjuvant chemotherapy Target Accrual: 4 (12 mths) ▪ Patients may receive post-operative chemotherapy for up to 24 weeks but must be registered for screening within 35 days of completion of adjuvant chemo (i.e. within 35 days of administration of last adjuvant chemotherapy Adult Cancer Clinical Research Fast Facts – March 2021 ▪ Screening registration within 90 days after final breast surgery if no adjuvant chemo, and within 270 days if adjuvant chemo was given ▪ ER, PR and HER2 negative, as well as ER and PR <= 5% positive or HER2 equivocal, breast cancers by ASCO/CAP guidelines with > 1 cm residual invasive cancer in the breast, or any invasive tumor in the lymph nodes, including N1 mic, after completion of 16-24 weeks of neoadjuvant chemotherapy ▪ Patients may receive post-operative chemotherapy for up to 24 weeks but must be registered for screening within 35 days of completion of adjuvant chemo (i.e. within 35 days of administration of last adjuvant chemotherapy) Orlando/Altamonte/Celebration ▪ Screening registration within 90 days after final breast surgery if no adjuvant chemo, and within 270 days if adjuvant chemo was given Exclusion: No active autoimmune disease or Hep B,C, no prior immunotherapy or active immunosuppressive therapy, no live vaccines within 30 days of registration. EA1131: A Randomized Phase III Post-Operative Trial of Platinum EA1131 Based Chemotherapy vs. Capecitabine in Patients with Residual ▪ Triple-Negative Breast Cancer following Neoadjuvant Adjuvant Chemotherapy Residual TNBC ▪ Clinical Stage II or III ▪ ER-, PR- criteria: < 10% cells stain positive, with weak intensity Actual Accrual: 10 score OR < 1% cells stain positive Target Accrual: 0 ▪ HER2- defined per ASCO/CAP guidelines ▪ Must have completed neoadjuvant taxane +/- anthracycline ▪ Must have completed definitive resection of primary tumor with negative margins. Patients with margins positive for LCIS are Open To Enrollment eligible ▪ Must found to have residual invasive cancer measuring > 1 cm and with more than minimal cellularity ▪ Radiotherapy may be given before or after protocol treatment per standard of care guildlines. Orlando/Altamonte ▪ Must have PAM50 anaylsis by digital mRNA quantitation on the FFPE block of residual disease Exclusion: Must not have received cisplatin, carboplatin or capecitabine A Randomized, Double-Blind, Phase III Trial of BR004 Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or ▪ Placebo in First-Line HER2-Positive Metastatic Breast Cancer Adult Cancer Clinical Research Fast Facts – March 2021 First Line Metastatic Her2 Positive ▪ Unresectable disease or metastatic disease ▪ Her-2 positive based on central testing Actual Accrual: 1 ▪ Localize palliative radiation is allowed >14 days prior to Target Accrual: 4 randomization Exclusion: Patients who receive a loading dose with a trastuzumab biosimilar will not be eligible Orlando/Altamonte/Celebration SGNTUC-016 --- Tucatinib Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for Metastatic subjects with unresectable locally-advanced or metastatic HER2+ HER2+ 1st or 2nd Line breast cancer ▪ Prior to randomization metastatic tumor tissue (archival or freshly obtained sample) must be submitted to the sponsor-designated central laboratory for confirmatory HER2 testing ▪ Must have history of prior treatment with a taxane and trastuzumab in any setting, separately or in combination. Prior pertuzumab therapy is allowed, but not required ▪ Must have progression of unresectable LA/M breast cancer after Target Accrual: 5 last systemic therapy (as confirmed by investigator), or be Actual Accrual: 1 intolerant of last systemic therapy Orlando ▪ Excludes prior treatment with T-DM1; tucatinib, lapatinib, neratinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. A Randomized, Open Label, Phase III Trial to Evaluate the ALLIANCE AFT-38 (PATINA) Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + ▪ Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine 1st Line Metastatic Therapy after Induction Treatment for Hormone Receptor Her2 +/HR + Positive (HR+)/HER2-Positive Metastatic Breast Cancer Target Accrual: 6 ▪ Histologically confirmed HER2+ and hormone receptor Actual Accrual: 2 positive (ER+ and/or PR+), metastatic breast cancer. Study will close to enrollment on 3.05.2021 Orlando Adult Cancer Clinical Research Fast Facts – March 2021 A Phase III Double-blind Randomised Study Assessing the D3615C00001 Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Metastatic Hormone Receptor Positive, Human Epidermal Growth 1st, 2nd & 3rd line Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment with an Aromatase Inhibitor (CAPItello-291) Target Accrual: ▪ Histologically confirmed HR+/HER2- breast cancer Accrual: 0 ▪ Patients are to have received treatment with an AI containing regimen (single agent or in combination) and have: o Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an AI, OR o (b) Radiological evidence of progression while on prior AI administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent
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