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Status: RecruitingPhase: Phase 2Diagnosis: Breast: Early Stage DiseaseNCT ID: NCT01670500
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-258
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.
Conducting Institutions: Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Dana Farber Cancer Institute at Faulkner Hospital, Brigham and Women's Hospital, Massachusetts General Hospital
Overall PI: Erica Mayer, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: Nadine Tung, MD,
Beth Israel Deaconess Medical CenterJudy Garber, MD,
Dana-Farber Cancer InstituteSteven Isakoff, MD, PhD,
Massachusetts General Hospital
Contacts: Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100