Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer
- Determine the confirmed complete and partial response rate in women with progressive
stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
- Determine the 6-month progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression
with estrogen and progesterone receptor status, response, survival, and time to disease
progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate* once daily on days 1-21 and oral capecitabine twice
daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or
NOTE: *If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose
will be increased in subsequent courses.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25
with non-measurable disease) will be accrued for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
Confirmed response rate (complete and partial)
Helen K. Chew, MD
University of California, Davis
United States: Federal Government