A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Registration Number
- NCT02032277
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 634
- Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
- Documented Breast Cancer Gene (BRCA) germline mutation testing.
- Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
- ECOG Performance status of 0 to 1.
- Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.
- Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
- Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
- Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
- A history of seizure within 12 months prior to study entry.
- Pre-existing neuropathy from any cause in excess of Grade 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Paclitaxel Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm A Cyclophosphamide Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm A Doxorubicin Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm C Placebo Placebo + placebo + paclitaxel followed by AC. Arm A Carboplatin Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm B Placebo Placebo + carboplatin + paclitaxel followed by AC Arm B Paclitaxel Placebo + carboplatin + paclitaxel followed by AC Arm A Veliparib Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) Arm B Cyclophosphamide Placebo + carboplatin + paclitaxel followed by AC Arm C Cyclophosphamide Placebo + placebo + paclitaxel followed by AC. Arm C Doxorubicin Placebo + placebo + paclitaxel followed by AC. Arm C Paclitaxel Placebo + placebo + paclitaxel followed by AC. Arm B Doxorubicin Placebo + carboplatin + paclitaxel followed by AC Arm B Carboplatin Placebo + carboplatin + paclitaxel followed by AC
- Primary Outcome Measures
Name Time Method Pathological Complete Response (pCR). At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). 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.
- Secondary Outcome Measures
Name Time Method Event Free Survival (EFS) Up to 4 years from the date of definitive surgery. 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.
Overall Survival (OS) Up to 4 years from the date of definitive surgery. OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.
Rate of eligibility for breast conservation after therapy (BCR). At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). 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.
Trial Locations
- Locations (158)
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
Scroll for more (148 remaining)Scottsdale Healthcare /ID# 120473🇺🇸Scottsdale, Arizona, United States