search
Back to results

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

Primary Purpose

Triple Negative Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine plus carboplatin plus BSI-201
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring triple negative breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Stanford Comprehensive Cancer Center
  • PrECOG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

standard chemotherapy plus BSI-201

Outcomes

Primary Outcome Measures

pathologic complete response

Secondary Outcome Measures

Full Information

First Posted
December 19, 2008
Last Updated
February 17, 2016
Sponsor
Sanofi
Collaborators
Breast Cancer Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00813956
Brief Title
A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Breast Cancer Research Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
triple negative breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
standard chemotherapy plus BSI-201
Intervention Type
Drug
Intervention Name(s)
gemcitabine plus carboplatin plus BSI-201
Intervention Description
iv, 3 week cycles
Primary Outcome Measure Information:
Title
pathologic complete response
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Comprehensive Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
PrECOG
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25847929
Citation
Telli ML, Jensen KC, Vinayak S, Kurian AW, Lipson JA, Flaherty PJ, Timms K, Abkevich V, Schackmann EA, Wapnir IL, Carlson RW, Chang PJ, Sparano JA, Head B, Goldstein LJ, Haley B, Dakhil SR, Reid JE, Hartman AR, Manola J, Ford JM. Phase II Study of Gemcitabine, Carboplatin, and Iniparib As Neoadjuvant Therapy for Triple-Negative and BRCA1/2 Mutation-Associated Breast Cancer With Assessment of a Tumor-Based Measure of Genomic Instability: PrECOG 0105. J Clin Oncol. 2015 Jun 10;33(17):1895-901. doi: 10.1200/JCO.2014.57.0085. Epub 2015 Apr 6.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs