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A Randomized Phase II trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women with Newly Diagnosed Breast Cancer and Germline BRCA Mutations

Conditions

Breast - Female | Breast - Male

What is the purpose of this trial?

Primary Objective The main goal of this study is to determine if the pathologic complete response (pCR) rate (determined by the Miller-Payne method 1) to neoadjuvant cisplatin is at least 20% greater than the pCR to doxorubicin/ cyclophosphamide (AC) in women with newly diagnosed breast cancer and a germline BRCA mutation. Secondary Objectives a. To determine the Residual Cancer Burden (RCB)2 after neoadjuvant cisplatin or doxorubicin/ cyclophosphamide (AC) in women with newly diagnosed breast cancer and a germline BRCA mutation. b. To determine the clinical response rate, defined as the number of partial and complete responses, after preoperative therapy with either cisplatin or AC in participants with a germline BRCA mutation and breast cancer. c. To compare the toxicities of cisplatin and AC preoperative chemotherapy in BRCA mutation carriers with newly diagnosed breast cancer. d. To collect pre-chemotherapy biopsies for future analyses of biomarkers that predict for response to cisplatin or AC chemotherapy in BRCA mutation carriers.

Participation Guidelines

Age:
Gender:
Female

Click here for detailed information about who can participate in this trial.


Sponsor:
Beth Israel Deaconess Medical Center
Dates:
09/16/2013
Last Updated:
Study HIC#:
1305012020