A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

Study Identifier
M12-914
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, Korean, Ukrainian, Turkish, Spanish (Latin America), French

Study Details

Medical Condition
  • Breast Cancer
  • Study Drug
  • Veliparib Placebo
  • Veliparib
  • Carboplatin
  • Paclitaxel
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.

    Study Locations

    Location
    Status
    Location
    Banner MD Anderson Cancer Ctr /ID# 125011
    Gilbert, Arizona, United States, 85234
    Status
    Not applicable
    Location
    University of Arkansas for Medical Sciences /ID# 124992
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    City of Hope /ID# 127117
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    California Cancer Associates for Research & Excellence (cCARE) /ID# 136078
    Fresno, California, United States, 93720
    Status
    Not applicable
    Location
    Moores Cancer Center at UC San Diego /ID# 124991
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Hematology and Oncology Assoc /ID# 130058
    Newport Beach, California, United States, 92663
    Status
    Not applicable
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