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)

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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)

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 objectives of the study are to assess the incidence of pCR plus minimal residual disease(defined as residual cancer burden [RCB] class I) and 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 chemotherapy-induced peripheral neuropathy (CIPN) as assessed
by the EORTC QLQ-CIPN20 questionnaire and NCI-CTCAE 4.0 grading for peripheral neuropathy,
Eastern Cooperative Oncology Group (ECOG) performance status, and breast cancer related quality of
life (QoL).

Protocol Number041312
Principal InvestigatorDeborah Toppmeyer
PhasePhase III
ScopeNational
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy multiple agents systemic
Surgery
Drugs InvolvedCYCLOPHOSPHAMIDE
PACLITAXEL
CARBOPLATIN
DOXORUBICIN
PLACEBO
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.