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
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Triple Negative Breast Cancer |
| Intervention | Drug: Veliparib Drug: Carboplatin Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide |
| Phase | Phase 3 |
| Sponsor | AbbVie |
| Responsible Party | AbbVie |
| ClinicalTrials.gov Identifier | NCT02032277 |
| First Received | December 13, 2013 |
| Last Updated | April 22, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 13, 2013 |
|---|---|
| Last Updated Date | April 22, 2014 |
| Start Date | January 2014 |
| Estimated Primary Completion Date | June 2016 |
| Current Primary Outcome Measures | Pathological Complete Response (pCR). [Time Frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).] [Designated as safety issue: No]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. Subjects who do not complete definitive surgery for reasons other than withdrawal of consent will be considered not to have achieved pCR. |
| Current Secondary Outcome Measures | Rate of eligibility for breast conservation after therapy (BCR). [Time Frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).] [Designated as safety issue: No]Whether a subject is eligible for breast conserving surgery will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy. |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
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| Official Title | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating 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 Triple Negative Breast Cancer (TNBC) |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Triple Negative Breast Cancer |
| Intervention | Drug: Veliparib Veliparib Drug: Carboplatin Carboplatin Drug: Paclitaxel Paclitaxel Drug: Doxorubicin Doxorubicin Drug: Cyclophosphamide Cyclophosphamide |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 624 |
| Estimated Completion Date | June 2016 |
| Estimated Primary Completion Date | June 2016 |
| Eligibility Criteria | Inclusion Criteria: 1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-4 N0-2 or T1 N1-2 by physical exam or radiologic studies. 2. Documented Breast Cancer Gene (BRCA) germline mutation testing. 3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast. 4. ECOG Performance status of 0 to 1. 5. 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. Exclusion Criteria: 1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer. 2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor. 3. 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. 4. A history of seizure within 12 months prior to study entry. 5. Pre-existing neuropathy from any cause in excess of Grade 1. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Brian Oliver, BS 847-938-5570 brian.oliver@abbvie.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02032277 |
|---|---|
| Other Study ID Numbers | M14-011 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | AbbVie |
| Study Sponsor | AbbVie |
| Collaborators | US Oncology Network National Surgical Adjuvant Breast and Bowel Project (NSABP) Grupo Espanol de Investigacion del Cancer de Mama Austrian Breast & Colorectal Cancer Study Group Alliance for Clinical Trials in Oncology German Breast Group |
| Investigators | Study Director: Mark McKee, MD AbbVie |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Site Reference ID/Investigator# 118035 | Whittier, California, United States, 90603 Principal Investigator: Site Reference ID/Investigator# 118035Recruiting |
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| Site Reference ID/Investigator# 118215 | Indianapolis, Indiana, United States, 46202 Principal Investigator: Site Reference ID/Investigator# 118215Recruiting |
| Site Reference ID/Investigator# 116815 | Lafayette, Indiana, United States, 47905 Principal Investigator: Site Reference ID/Investigator# 116815Recruiting |
| Site Reference ID/Investigator# 118775 | Kansas City, Missouri, United States, 64111 Principal Investigator: Site Reference ID/Investigator# 118775Recruiting |
| Site Reference ID/Investigator# 119179 | Asheville, North Carolina, United States, 28806 Principal Investigator: Site Reference ID/Investigator# 119179Recruiting |
| Site Reference ID/Investigator# 118677 | Salt Lake City, Utah, United States, 84112 Principal Investigator: Site Reference ID/Investigator# 118677Recruiting |