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

Triple Negative Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813956
• Other study ID #: TCD11487
• Secondary ID: 20080206
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: February 17, 2016
• Start date: December 2008
• Est. completion date: October 2012

Study information

• Verified date: February 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• gemcitabine plus carboplatin plus BSI-201
iv, 3 week cycles

Locations

Country	Name	City	State
United States	PrECOG	Philadelphia	Pennsylvania
United States	Stanford Comprehensive Cancer Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response		4 months	No