Clinical Research Directory
Browse clinical research sites, groups, and studies.
Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
Sponsor: Beth Israel Deaconess Medical Center
Summary
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.
Official title: A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2012-10
Completion Date
2025-02-02
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
Cisplatin
administered intravenously every 3 weeks for 4 doses
Cyclophosphamide
administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin
administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
Locations (15)
University of Colorado Cancer Center
Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Derby
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center at Guilford
Guilford, Connecticut, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
Yale School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Duke University
Durham, North Carolina, United States
Women and Infants Hospital
Providence, Rhode Island, United States
MD Anderson Cancer Center
Houston, Texas, United States