A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer

Study Overview
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Brief Summary
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This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery. 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.

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: gemcitabine plus carboplatin plus BSI-201


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: invasive breast cancer 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: Metastatic breast cancer 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>standard chemotherapy plus BSI-201 | Drug: gemcitabine plus carboplatin plus BSI-201<br>* iv, 3 week cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic complete response |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triple negative breast cancer