A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

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A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

Objectives: The primary objective of the study is to assess the progression-free survival (PFS) of oral
veliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel
compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and
metastatic breast cancer.
The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR),
and objective response rate (ORR) in those subjects treated with veliparib plus TMZ or treated with
veliparib plus carboplatin and paclitaxel versus placebo plus carboplatin and paclitaxel.
The tertiary objectives are to assess Eastern Cooperative Oncology Group (ECOG) performance status
and quality of life (QoL).

Protocol Number041110
Principal InvestigatorDeborah Toppmeyer
PhasePhase II
ScopeNational
Applicable Disease SitesBreast - Male
Breast - Female
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedCARBOPLATIN
ABT-888
PLACEBO
TEMOZOLOMIDE
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.