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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Triple Negative Breast Cancer

Treatments: Drug: gemcitabine plus carboplatin plus BSI-201

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00813956

TCD11487

20080206 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

1

Experimental group

Description:

standard chemotherapy plus BSI-201

Treatment:

Drug: gemcitabine plus carboplatin plus BSI-201