A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC)
Primary Objective: to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed by doxorubicin + cyclophosphamide compared to two neoadjuvant
chemotherapy regimens (paclitaxel followed by doxorubicin + cyclophosphamide; carboplatin and
paclitaxel followed by doxorubicin + cyclophosphamide) with matching placebo in subjects with
triple negative breast cancer.
Patient Population: ER-, PR-, and HER2-negative (triple-negative) breast cancer patientswho are candidates for potentially curative surgery
Target Accrual: 624 patients
Status: Active. Not recruiting participants
ClinicalTrials.gov Identifier: NCT02032277
The Mission of NSABP Foundation, Inc. is to design and conduct practice changing cancer research, including clinical trials and laboratory studies in the medical, surgical and prevention settings in order to improve the survival outcome and quality of life of patients with breast and colorectal cancer, and to disseminate the results of NSABP collaborative research to benefit the world-wide community.
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