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Completed

NCT Number: NCT00813956

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

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.

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Comprehensive Cancer Center, Stanford, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemcitabine plus carboplatin plus BSI-201

Drug

iv, 3 week cycles

Primary outcomes

  1. pathologic complete response

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Breast Cancer Research Foundation

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2008
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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