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

Launched by SANOFI · Dec 19, 2008

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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

Trial Officials