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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ClinicalTrials.gov Identifier: NCT02032277 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 10, 2014
Last Update Posted
: January 17, 2018
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Sponsor:
AbbVie
Collaborators:
German Breast Group
NSABP Foundation Inc
Grupo Español de Investigación del Cáncer de Mama
US Oncology Research
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
AbbVie
Tracking Information | |||||||
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First Submitted Date ICMJE | December 13, 2013 | ||||||
First Posted Date ICMJE | January 10, 2014 | ||||||
Last Update Posted Date | January 17, 2018 | ||||||
Actual Study Start Date ICMJE | April 2, 2014 | ||||||
Actual Primary Completion Date | March 18, 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Pathological Complete Response (pCR). [ Time Frame: 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. Subjects who do not complete definitive surgery for reasons other than withdrawal of consent will be considered not to have achieved pCR.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT02032277 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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). ] 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.
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Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE |
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Descriptive Information | |||||||
Brief Title ICMJE | 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 | ||||||
Official Title ICMJE | 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 ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Triple Negative Breast Cancer | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
634 | ||||||
Original Estimated Enrollment ICMJE |
624 | ||||||
Estimated Study Completion Date | November 2, 2020 | ||||||
Actual Primary Completion Date | March 18, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 99 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Russian Federation, Spain, Taiwan, United Kingdom, United States | ||||||
Removed Location Countries | Czech Republic, Israel, Poland | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02032277 | ||||||
Other Study ID Numbers ICMJE | M14-011 2013-002377-21 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | AbbVie | ||||||
Study Sponsor ICMJE | AbbVie | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | AbbVie | ||||||
Verification Date | January 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |