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

Completed · Phase 2

Conditions studied: Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT00813956

Run by

Sanofi

People needed

80

Starts

2008-12-01

Expected to finish

2012-10-01

Last updated by the study team

2016-03-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford Comprehensive Cancer Center — Stanford, California, United States
• PrECOG — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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