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
Study Drug
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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