NSABP B-56-I
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NSABP B-56-I - AbbVieM14-011

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