At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 294 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Placebo, Veliparib, and 3 other interventions for Metastatic Breast Cancer. Completed, enrolled 294 participants across 120 sites in 20 countries.
Detailed Summary
The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesArgentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Hungary, Israel, Netherlands, Norway, Poland, Romania, Russia, Spain, Sweden, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2012
Enrollment StartJan 2012
Primary CompletionDec 2018
Study CompletionSep 2020
TodayJul 2026
First PostedJan 10, 2012
Enrollment StartJan 23, 2012
Primary CompletionDec 13, 2018
Study CompletionSep 2, 2020
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 14.5 years ago
Interventions
Placebodrug
Veliparibdrug
Carboplatindrug
Temozolomidedrug
Paclitaxeldrug