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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00813956
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Sanofi

Study Description
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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

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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


Outcome Measures
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Primary Outcome Measures :
  1. pathologic complete response [ Time Frame: 4 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813956


Locations
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United States, California
Stanford Comprehensive Cancer Center
Stanford, California, United States, 94305
United States, Pennsylvania
PrECOG
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Sanofi
Breast Cancer Research Foundation
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00813956    
Other Study ID Numbers: TCD11487
20080206 ( Other Identifier: BiPar )
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: February 2016
Keywords provided by Sanofi:
triple negative breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Gemcitabine
 Iniparib
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors