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

February 17, 2016 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • PrECOG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pathologic complete response
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Breast Cancer Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCD11487
  • 20080206 (Other Identifier: BiPar)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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