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AAMC Breast Cancer- Current Research Protocols To consider a patient for participation in a trial, please contact Emily Ross at ext.4392 or Venita Crawford at ext.4393 (Press CTRL + Study Acronym for specific study information) AAMC Breast Trials Breast Cancer Research Program PREOPERATIVE WINDOW/PERIOPERATIVE N/A ActiveEnrolling Walter Reed Tissue and Blood Library Establishment for Molecular, Biochemical and Histologic Study of Breast Disease PI: Tafra N/A ActiveEnrolling Heterogeneity: Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens? PI: Tafra NEOADJUVANT TREATMENT OTHER NSABPB51 ActiveEnrolling Updated: 12/Feb/2015 XRT/WBI Pre/Postmenopausal NSABP B-51: A Randomized Phase III Clinical Trial Evaluating PostMastectomy Chest Wall and Regional Nodal XRT and PostLumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy PI: Young Page 1 of 4 AAMC Breast Cancer- Current Research Protocols To consider a patient for participation in a trial, please contact Emily Ross at ext.4392 or Venita Crawford at ext.4393 (Press CTRL + Study Acronym for specific study information) ADJUVANT CHEMOTHERAPY PBI3 KAITLIN ER- ActiveEnrolling PBI ActiveEnrolling Trastuzumab+ Pertuzumab Pre/Postmenopausal Segmental mastectomy HER2+ Pre/Postmenopausal J13104: A Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with ER Negative Early Stage Breast Cancer (KAITLIN): A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab plus Pertuzumab plus Taxane following Anthracyclines versus Trastuzumab Emtansine plus Pertuzumab following Anthracyclines as Adjuvant Therapy in Patients with Operable HER2-Postive Primary Breast Cancer PI: Young PI: Tweed HORMONAL THERAPY S1207 ActiveEnrolling Everolimus (mTOR) HR+/HER2Pre/Postmenopausal Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy. PI: Tweed RADIATION THERAPY None OTHER None Updated: 12/Feb/2015 Page 2 of 4 AAMC Breast Cancer- Current Research Protocols To consider a patient for participation in a trial, please contact Emily Ross at ext.4392 or Venita Crawford at ext.4393 (Press CTRL + Study Acronym for specific study information) METASTATIC HORMONAL THERAPY CHEMOTHERAPY/OTHER THERAPY METRIC ABRAZO A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study) ActiveEnrolling CDX-011 (mAb vs. GPNMB) TNBC Pre/Postmenopausal ActiveEnrolling BMN673 A Phase 2, 2-Stage, 2-Cohort Study of BMN 673 Administered to BRCA1 or BRCA2 mutation Germline BRCA Mutation Subjects with Locally Advanced and/or Pre/Post Menopausal Metastatic Breast Cancer (BioMarin) PI: Weng PI: Weng IMMUNOTHERAPY Updated: 12/Feb/2015 Page 3 of 4 AAMC Breast Cancer- Current Research Protocols To consider a patient for participation in a trial, please contact Emily Ross at ext.4392 or Venita Crawford at ext.4393 (Press CTRL + Study Acronym for specific study information) METASTATIC (continued) OTHER CLOSED A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer NSABP B-47 ActiveClosed To Enrollment NSABP B-43 ActiveClosed To Enrollment A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy MARIANNE ActiveClosed to Enrollment A randomized, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane,as first line treatment in HER2 positive progressive or recurrent locally advanced or metastatic breast cancer (MBC) Updated: 12/Feb/2015 PI: Werner PI: Garg PI: Werner Page 4 of 4
