This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
634
Pathological Complete Response (pCR).
Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.
Time frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).
Event Free Survival (EFS)
EFS will be defined as the time from random assignment to documentation of the first of the following events: discontinuation of study therapy due to protocol-defined progression prior to surgery; local, regional, or distant recurrence of breast cancer following curative surgery; a new breast cancer; another new onset malignancy; or death as a result of any cause.
Time frame: Up to 4 years from the date of definitive surgery.
Overall Survival (OS)
OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.
Time frame: Up to 4 years from the date of definitive surgery.
Rate of eligibility for breast conservation after therapy (BCR).
Whether a subject is eligible for breast conserving surgery for whom mastectomy was planned at diagnosis will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy.
Time frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).
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Paclitaxel
Carboplatin
Veliparib
Placebo for Veliparib
Scottsdale Healthcare /ID# 120473
Scottsdale, Arizona, United States
Mayo Clinic - Scottsdale /ID# 139932
Scottsdale, Arizona, United States
Arizona Oncology Associates, PC-HOPE /ID# 126137
Tucson, Arizona, United States
Usc /Id# 123310
Los Angeles, California, United States
Pacific Cancer Care /ID# 120476
Salinas, California, United States
Sharp Memorial Hospital /ID# 119861
San Diego, California, United States
Stanford University School of Med /ID# 130316
Stanford, California, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 137275
West Hollywood, California, United States
Christiana Care Health Service /ID# 137823
Newark, Delaware, United States
Florida Cancer Specialists - Fort Myers /ID# 121835
Fort Myers, Florida, United States
...and 148 more locations