Status:
COMPLETED
A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00813956
Start Date
December 1 2008
End Date
October 1 2012
Last Update
March 17 2016
Active Locations (2)
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1
Stanford Comprehensive Cancer Center
Stanford, California, United States, 94305
2
PrECOG
Philadelphia, Pennsylvania, United States, 19103