A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
NCT ID: NCT00813956
Last Updated: 2016-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2008-12-31
2012-10-31
Brief Summary
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Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
standard chemotherapy plus BSI-201
gemcitabine plus carboplatin plus BSI-201
iv, 3 week cycles
Interventions
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gemcitabine plus carboplatin plus BSI-201
iv, 3 week cycles
Eligibility Criteria
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Inclusion Criteria
* stage I-IIIA disease
* ER, PR, Her2/neu-negative status
* no prior treatment for breast cancer
* age 18 years of greater
* normal renal, liver function
* normal hematologic status
* ECOG Performance status 0, 1
* Evaluation by a surgeon to determine breast conservation eligibility
* Women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Inoperable breast cancer, including Stage IIIB and IIIC
* Tumor size less than 1 centimeter
* Prior surgery, systemic therapy, or radiotherapy for the current cancer
* Hormone receptor-positive breast cancer
* Her2/neu-positive breast cancer
* Any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
* Pregnant or nursing women
* Receipt of any investigational agents within 30 days prior to commencing study treatment
18 Years
FEMALE
No
Sponsors
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Breast Cancer Research Foundation
OTHER
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Stanford Comprehensive Cancer Center
Stanford, California, United States
PrECOG
Philadelphia, Pennsylvania, United States
Countries
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References
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Telli ML, Jensen KC, Vinayak S, Kurian AW, Lipson JA, Flaherty PJ, Timms K, Abkevich V, Schackmann EA, Wapnir IL, Carlson RW, Chang PJ, Sparano JA, Head B, Goldstein LJ, Haley B, Dakhil SR, Reid JE, Hartman AR, Manola J, Ford JM. Phase II Study of Gemcitabine, Carboplatin, and Iniparib As Neoadjuvant Therapy for Triple-Negative and BRCA1/2 Mutation-Associated Breast Cancer With Assessment of a Tumor-Based Measure of Genomic Instability: PrECOG 0105. J Clin Oncol. 2015 Jun 10;33(17):1895-901. doi: 10.1200/JCO.2014.57.0085. Epub 2015 Apr 6.
Other Identifiers
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20080206
Identifier Type: OTHER
Identifier Source: secondary_id
TCD11487
Identifier Type: -
Identifier Source: org_study_id
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