Phase II Dasatinib Study in Advanced Breast Cancer

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to find out if dasatinib will safely reduce the size or spread of your tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Bristol-Myers Squibb
• Treatments: Dasatinib

Criteria

Inclusion Criteria:

• Measurable Stage IV or inoperable Stage III advanced breast cancer.

• There is no limit on the number of prior therapies.

• At least 3 weeks since prior chemotherapy, biological or hormonal therapy.

• At least 2 weeks since surgical biopsy.

• At least 3 weeks since major (open thoracic/abdominal/cardiac) surgery.

• No central nervous system (CNS) metastases except solitary brain metastasis

• No cardiac dysfunction

• left ventricular ejection fraction (LVEF) ≥ 50% as determined by multiple gated acquisition scan (MUGA)/echocardiogram

• Adequate blood counts

• Normal liver and kidney function

• Negative serum pregnancy test.

• Able to provide informed consent

Exclusion Criteria:

• Pregnant or breast feeding.

• Prior treatment with dasatinib.

• Bone as the only site of disease.

• Significant gastrointestinal bleeding

• Septicemia, infection, acute hepatitis, hypokalemia, or hypomagnesemia