Breast Cancer Clinical Trial
Official title:
Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes
necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in
different ways to stop tumor cells from dividing so they stop growing or die. Combining
imatinib mesylate with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with
capecitabine works in treating women with progressive stage IV breast cancer.
OBJECTIVES:
- 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
unacceptable toxicity.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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