Clinical Trials - Breast cancer

Study	Objective	Contact
A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) versus AI Alone in Women with Metastatic Breast Cancer (MBC)	This study is being done to find out what effects (good or bad) the combination of the experimental drug MEDI-573 and another kind of anticancer drugs called aromatase inhibitors (AIs) has on you and your breast cancer. As part of this study, researchers would also like to do laboratory testing on tissue samples and blood samples to find out as much as possible about breast cancer and how this treatment might affect the disease.	Principal Investigator(s): Corrine Zarwan, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Kori D. Hesse.
A Phase III Randomized, Double-Blind, Placebo-Controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer	Over the past few years, there has been a huge increase in our knowledge about the important role that hereditary factors (genes) play in the origin and treatment of diseases. Genes are made up of deoxyribonucleic acid (DNA), which is found in your blood cells and tissues. We now have some indication of how the genetic ‘makeup’ of an individual may influence his/her reaction to a specific drug, in terms of both wanted and unwanted effects. The goal of this Research Study is to identify and analyze genes that are associated with your cancer.	Principal Investigator(s): Corrine Zarwan, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Kori D. Hesse.
Molecular Analysis of Cancer	The purpose of this research is to discover molecular changes involved in cancer. We hope that a better understanding of these changes can improve cancer management. This research may include genetic and/or genomic analysis (tests to determine and compare your genetic sequence, or DNA). Some of the tissue we collect for our research may be submitted to the National Cancer Institute Cancer Genome Atlas Project. The goal of this project is to determine the genomic changes involved in more than 20 types of human cancer.	Principal Investigator(s): Kimberly R. Christ, PhD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Doreen L. Browne, ,CCRP, Jane S. Nalwalk, Linda M. Topjian.
NSABP B-39/RTOG 0413: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) For Women With Stage 0, I, II Breast Cancer	A study comparing radiation to the entire breast to radiation to only part of the breast.	Principal Investigator(s): Lyubov Girshovich, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Donna Cossar, Kori D. Hesse, Su Aras.
NSABP B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node Positive or High-Risk Node-Negative HER2-Negative Breast Cancer	This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.	Principal Investigator(s): Corrine Zarwan, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Kori D. Hesse.
NSABP Protocol 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 is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy. Radiation therapy is the standard treatment for patients with DCIS.	Principal Investigator(s): Stephen E. Karp, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Kori D. Hesse.
PRESENT: Prevention of Recurrence in Early Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment	The purpose of this study is to evaluate the safety and effectiveness of the investigational drug, NeuVax, in preventing the recurrence of node-positive (when cancer is found in the lymph nodes), early stage breast cancer, with low to intermediate HER2 expression (Her-2 negative). NeuVax is an investigational drug, which means it is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). It is a protein vaccine being developed for use after completion of standard of care therapy for early stage breast cancer to potentially prevent recurrence of the cancer. The safety of NeuVax in humans has been tested in prior research studies. This study will continue to collect information on safety, and will test NeuVax’s effectiveness.	Principal Investigator(s): Corrine Zarwan, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Kori D. Hesse.
S0812, A Randomized, Double-Blind, Placebo-Controlled, Biomarker Modulation Study of High Dose Vitamin D in Premenopausal Women at High Risk for Breast Cancer, Phase IIB	A biomarker is a biologic test (for example, a mammogram, tissue or blood test) which may predict who will develop breast cancer in the future. The purpose of this study is to see if vitamin D affects breast tissue by reducing breast tissue thickness (the amount of glandular breast tissue compared to fat) on a mammogram (a special imaging exam of the breast that uses x-rays) and if it reduces the growth of breast cells. Also, we want to find out what effects on the breast and also side effects vitamin D has.	Principal Investigator(s): Corrine Zarwan, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Julia C. Roache.
S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less	The Oncotype DX® breast cancer test is a test that looks at multiple genes related to breast cancer. The combination of the test results produces a score that is useful in guiding treatment choices for patients with node-negative breast cancer. The higher the score, the more likely that the patient’s breast cancer will come back after surgery. The Oncotype DX® test is a commercially available test that is already being used to assess the risk that breast cancer will come back after surgery. The performance of the test is not part of the research question in this study. The purpose of this part of this experimental study is to send your breast cancer tissue for Oncotype DX® recurrence score testing to find out if you may be eligible to participate in the next part of the study.	Principal Investigator(s): Corrine Zarwan, MD For more information about this Research Study call 781-744-8027. Study Coordinator(s): Deb Hanna, RN, Jo A. Underhill, Kori D. Hesse.