A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Eva

The primary objective of the study is 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. The secondary objective of the study is to assess the rate of eligibility for breast conservation after therapy (BCR). The tertiary objectives are to assess event free survival (EFS), overall survival (OS), clinical response rate (CRR) at 12 weeks, incidence of pCR plus minimal residual disease (defined as residual cancer burden [RCB] class I), Eastern Cooperative Oncology Group (ECOG) performance status, and breast cancer related quality of life (QoL).

September 25, 2015