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Breast Cancer

S1207: 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
The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer
Website: http://clinicaltrials.gov/ct2/show/NCT01674140?term=S1207&rank=1
Principal Investigator:  Carol Tweed, M.D.
Research Coordinators:  Emily Ross, CCRC  (443) 481-4392
                                                          Venita Alston Crawford, RN  (443)481-4393

J1259: A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment
This research is being done to find out if the investigational drug BKM120 is safe and effective when given with fulvestrant (Faslodex) to postmenopausal women whose hormone receptor-positive beast cancer has progressed on or after aromatase inhibitor treatment.
Website: http://www.clinicaltrial.gov/ct2/show/NCT01610284?term=belle2&rank=1
Principal Investigator:  Jeanine Werner, MD
Research Coordinator:   Venita Alston Crawford, RN  (443) 481-4393
                                                          Emily Ross, CCRC (443) 481-4392

M12-895: A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
This research is being done to determine if patients with BRCA1 or BRCA2 mutation and metastatic breast cancer do better with veliparib in combination with temozolomide or carboplantin and paclitaxel with or without veliparib.
Website:  http://clinicaltrials.gov/ct2/show/NCT01506609?term=veliparib+AND+BRCA&rank=1
Principal Investigator: 
Jeanine Werner, MD
Research Coordinator:   Venita Alston Crawford, RN  (443) 481-4393
                                                          Emily Ross, CCRC (443) 481-4392

NSABP B-47: 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
The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning. A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer.
Website: http://clinicaltrials.gov/ct2/show/NCT01275677?term=BREAST+NSABP+B-47&rank=1
Principal Investigator: Jeanine Werner, M.D.
Research Coordinator:  Venita Alston Crawford, R.N. (443) 481-4393

NSABP B-43: 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
This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.
Website:  http://clinicaltrials.gov/ct2/show/NCT00769379?term=bREAST+NSABP+B-43&rank=1
Principal Investigator:  Ravin Garg, MD
Research Coordinator:   Venita Alston Crawford, R.N. (443) 481-4393 

E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer. Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer,
Principal Investigator: 
Robert Buras, MD
Research Coordinator:  Kristen Sawyer, CCRA (443)481-5749

Tissue and Blood Library Establishment for Molecular, Biochemical and Histologic Study of Breast Disease
The purpose of this clinical trial is to collect breast tissue, lymph node tissue, blood samples and data (information) about patient health for use in current and future research studies on breast cancer and breast diseases.  It is also possible that this blood and tissue may be used in research to learn more about other types of cancer and other diseases. The research that may be done with the blood or tissue collected is not designed specifically to help the patient from whom it is collected. This study is for patients that are scheduled to have part of all of their breast tissue surgically removed as part of their clinical care.
Principal Investigator:   Dr. Lorraine Tafra – (443)481-5300
Research Coordinator:

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