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COMPLETED
NCT01670500
PHASE2

Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

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

DRUG

Cisplatin

administered intravenously every 3 weeks for 4 doses

DRUG

Cyclophosphamide

administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses

DRUG

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