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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

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

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

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