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 Number | 041110 |
|---|---|
| Principal Investigator | Deborah Toppmeyer |
| Phase | Phase II |
| Scope | National |
| Applicable Disease Sites | Breast - Male Breast - Female |
| Therapies Involved | Chemotherapy multiple agents systemic |
| Drugs Involved | CARBOPLATIN PACLITAXEL PLACEBO TEMOZOLOMIDE ABT-888 |
| Participating Institutions | The Cancer Institute of New Jersey |
For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.
