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
  • Breast Cancer
  • Study Drug
  • Placebo
  • Veliparib
  • Carboplatin
  • Temozolomide
  • Paclitaxel
  • 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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