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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00813956

Collaborator

Breast Cancer Research Foundation (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer	Drug: gemcitabine plus carboplatin plus BSI-201	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 standard chemotherapy plus BSI-201	Drug: gemcitabine plus carboplatin plus BSI-201 iv, 3 week cycles

Arm

Intervention/Treatment

Experimental: 1

standard chemotherapy plus BSI-201

Drug: gemcitabine plus carboplatin plus BSI-201

iv, 3 week cycles

Outcome Measures

Primary Outcome Measures

pathologic complete response [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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