Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Early Stage Disease
NCT 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 Center
Judy Garber, MD, Dana-Farber Cancer Institute
Steven Isakoff, MD, PhD, Massachusetts General Hospital

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Pathologic confirmation of invasive breast cancer - Stage: Clinical T1 > 1.5 cm, T2 or T3, N0-3, M0 - HER2 negative - If tumor is ER+, it must be grade 2 or 3 or must have oncotype recurrence score > 31 - ER and PgR status by immunohistochemistry must be known - Life expectancy greater than six months - Use of an effective means of contraception is required Exclusion Criteria: - Pregnant or breastfeeding - Prior chemotherapy at any time - Prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy - Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer - Peripheral neuropathy of any etiology that exceeds grade 1 - Significant hearing loss - Renal dysfunction - Use of other investigational or study agents - History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs - Uncontrolled intercurrent illness - Any condition that would prohibit administration of corticosteroids - Uncontrolled diabetes - Pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE - Known HIV positive individuals on combination antiretroviral therapy
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