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

Phase 2

Completed

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: gemcitabine plus carboplatin plus BSI-201

• Registration Number: NCT00813956
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-23
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-17
• Disposition First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Disposition First Posted: 2016-03-17
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	gemcitabine plus carboplatin plus BSI-201	standard chemotherapy plus BSI-201

Primary Outcome Measures

Name	Time	Method
pathologic complete response	4 months

Trial Locations

Locations (2)

Stanford Comprehensive Cancer Center; 🇺🇸 Stanford, California, United States

PrECOG; 🇺🇸 Philadelphia, Pennsylvania, United States