Phase II Dasatinib Study in Advanced Breast Cancer

Completed · Phase 2

Conditions studied: Advanced Breast Cancer

In brief

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

Key facts

Study ID

NCT00546104

Run by

Duke University

People needed

31

Starts

2007-10-01

Expected to finish

2011-05-01

Last updated by the study team

2013-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Palm Beach Cancer Center Institute — West Palm Beach, Florida, United States
• Presbyterian Health Care — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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