Breast Cancer Clinical Trial
A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
Summary
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.
Eligibility Criteria
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
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There are 2 Locations for this study
Stanford California, 94305, United States
Philadelphia Pennsylvania, 19103, United States
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