PER Pulse Recap Currently Recruiting Clinical Trials Reference List Surgery Clinicaltrials.gov Principal Investigator/ Title Phase Identifier Study Chair A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in 3 NCT01242800 Seema A. Khan, MD Robert H. Lurie Cancer Center Patients With Metastatic Breast Cancer Adjuvant Therapy Clinicaltrials.gov Principal Investigator/ Title Phase Identifier Study Chair A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast 3 NCT01272037 Ana Maria Gonzalez-Angulo Southwest Oncology Group Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: a Clinical Trial Rx or Positive Node, Endocrine Responsive Breast Cancer A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide Norman Wolmark, MD with Anthracycline-Based Chemotherapy Regimens 3 NCT01547741 National Surgical Adjuvant Breast and for Women With Node-Positive or High-Risk Node- Bowel Project Foundation, Inc. Negative, HER2-Negative Breast Cancer A Randomized Multicenter, Double-Blind, Placebo- Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy 3 NCT01358877 Hoffmann-La Roche Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer (APHINITY) A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive 3 NCT01772472 Hoffmann-La Roche Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy 1 30th Annual Miami Breast Cancer Conference®: Clinical Trials Reference List CurrentlyPER Pulse RecruitingRecap Clinical Trials Reference List Neoadjuvant Therapy Clinicaltrials.gov Principal Investigator/ Title Phase Identifier Study Chair I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And 2 NCT01042379 Laura Esserman, MD, MBA University of California, San Francisco moLecular Analysis 2) A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens With Weekly Paclitaxel Plus Neratinib or Trastuzumab or Neratinib Norman Wolmark, MD and Trastuzumab Followed by Doxorubicin and 2 NCT01008150 National Surgical Adjuvant Breast and Cyclophosphamide With Postoperative Trastuzumab in Bowel Project Foundation, Inc. Women With Locally Advanced HER2-Positive Breast Cancer A Phase II Neo-Adjuvant Study of Cisplatin, and Paclitaxel With or Without RAD001 in Patients With 2 NCT00930930 Ingrid Mayer, MD Vanderbilt-Ingram Cancer Center Triple-Negative Locally Advanced Breast Cancer An Adaptive, Randomized Phase II Trial to Determine Pathologic Complete Response With the Addition of Carboplatin With and Without Veliparib to Standard 2 NCT01818063 Tiffany Avery, MD, MPH Thomas Jefferson University Chemotherapy in the Neoadjuvant Treatment of Triple- Negative Breast Cancer Metastatic Breast Cancer Clinicaltrials.gov Principal Investigator/ Title Phase Identifier Study Chair A Phase III, Randomized, Double-Blind, Placebo- Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Bevacizumab and Associated Biomarkers in Combination With Paclitaxel Compared With 3 NCT01663727 Hoffmann-La Roche Paclitaxel Plus Placebo as First-Line Treatment of Patients With HER2-Negative Metastatic Breast Cancer (MERiDiAN) A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With 3 NCT01250379 Hoffmann-La Roche Locally Recurrent or Metastatic Breast Cancer After First-Line Chemotherapy and Bevacizumab Treatment A Phase III Randomized, Double Blind, Placebo- Controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of 3 NCT01234337 Bayer Healthcare AG Locally Advanced or Metastatic HER2-Negative Breast Cancer 2 30th Annual Miami Breast Cancer Conference®: Clinical Trials Reference List CurrentlyPER Pulse RecruitingRecap Clinical Trials Reference List Metastatic Breast Cancer Continued Clinicaltrials.gov Principal Investigator/ Title Phase Identifier Study Chair The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician’s Choice (TPC) in Patients With Locally 3 NCT01492101 Robert Medve, MD Nektar Therapeutics Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane, and Capecitabine A Phase III Randomized, Double-Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor- 3 NCT01610284 Novartis Pharmaceuticals positive HER2-Negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment (BELLE-2) A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) and/or 2 NCT01186991 See-Chun Phan, MD Genentech Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple- Negative Breast Cancer Reversing Hormone Resistance in Advanced Breast 2 NCT01466972 Hope Rugo, MD Cancer With Pazopanib University of California, San Francisco A Phase II Study of TKI258 (Dovitinib Lactate) as Salvage Therapy in Patients With Stage IV HER2- 2 NCT01262027 Ricardo Alvarez, MD Negative Inflammatory Breast Cancer (IBC) and Local UT MD Anderson Cancer Center or Distant Relapse Phase 1 Trials Principal Molecular Patient Clinicaltrials.gov Investigator/ Title Target Population Identifier Study Chair Phase I/II Study of Cediranib and VEGFR1, 2, 3 Olaparib in Combination for Treatment (cediranib) Recurrent, triple- of Recurrent Papillary-Serous Ovarian, Joyce Liu, MD Poly negative breast NCT01116648 Dana-Farber Cancer Fallopian Tube, or Peritoneal Cancer (ADP-ribose) cancer Institute or for Treatment of Recurrent Triple- polymerase Negative Breast Cancer (olaparib) 3 30th Annual Miami Breast Cancer Conference®: Clinical Trials Reference List CurrentlyPER Pulse RecruitingRecap Clinical Trials Reference List Phase 1 Trials Continued Principal Molecular Patient Clinicaltrials.gov Investigator/ Title Target Population Identifier Study Chair A Phase Ib Trial of BYL719 (an α-Specific PI3K Inhibitor) in Postmenopausal, Combination With Endocrine Therapy hormone Ingrid Mayer PI3K NCT01791478 Vanderbilt-Ingram Cancer in Post-Menopausal Patients With receptor-positive Center Hormone Receptor-Positive Metastatic MBC Breast Cancer An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 Locally advanced in Patients With Locally Advanced or metastatic or Metastatic Solid Tumors and in PI3K hormone NCT01296555 Genentech Combination With Endocrine Therapy receptor-positive in Patients With Locally Advanced or breast cancer Metastatic Hormone Receptor-Positive Breast Cancer A Phase Ib, Open-Label, Dose- Escalation Study of the Safety and Pharmacology of PI3-Kinase Inhibitor GDC-0941 in Combination Locally recurrent PI3K NCT00960960 Gallia Levy, MD, PhD With Paclitaxel, With and Without or MBC Genentech Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer A Dose-Finding Phase Ib Study Followed by an Open-Label, HER2-negative, Randomized Phase II Study of BEZ235 inoperable Novartis PI3K/mTOR NCT01495247 Plus Paclitaxel in Patients With HER2 locally advanced Pharmaceuticals Negative, Inoperable Locally Advanced or MBC or Metastatic Breast Cancer A Phase 1b Dose-Escalation Study of the AKT Inhibitor MK-2206 (NSC#749607) Plus Lapatinib HER2-positive Patricia LoRusso PI3K/mTOR NCT01281163 Barbara Ann Karmanos (NSC#727989) Administered MBC Cancer Institute in Patients With HER2 Positive Metastatic Breast Cancer A Phase 1 Trial of MK-2206 in Combination With Anastrozole, Cynthia Ma Fulvestrant, or Anastrozole Plus AKT1,2,3 ER-positive MBC NCT01344031 Washington University Fulvestrant in Postmenopausal School of Medicine Women With Estrogen Receptor- Positive Metastatic Breast Cancer 4 30th Annual Miami Breast Cancer Conference®: Clinical Trials Reference List.