Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
Study Identifier
M12-895
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Czech, Danish, Dutch (Belgium), Dutch, French, Ukrainian
Study Details
Medical Condition
Study Drug
Phase
Phase 2
Sex
Female & Male
Age
18+ years
Protocol 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 Locations
Location
Status
Location
University of Alabama at Birmingham - Main /ID# 62994
Birmingham, Alabama, United States, 35233
Status
Not applicable
Location
Banner MD Anderson Cancer Ctr /ID# 118695
Gilbert, Arizona, United States, 85234
Status
Not applicable
Location
University of Arkansas for Medical Sciences /ID# 60750
Little Rock, Arkansas, United States, 72205
Status
Not applicable
Location
Moore UC San Diego Cancer Center /ID# 60754
La Jolla, California, United States, 92093
Status
Not applicable
Location
The Angeles Clinic and Researc /ID# 60743
Los Angeles, California, United States, 90025
Status
Not applicable
Location
Stanford University School of Med /ID# 65488
Stanford, California, United States, 94305-2200
Status
Not applicable
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