Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic breast cancer. Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth
PRIMARY OBJECTIVES: I. To determine the efficacy of STI571 in metastatic breast cancer (MBC) that demonstrates expression of CD117 (c-kit) and/ or PDGFR. SECONDARY OBJECTIVES: I. To determine the clinical activity of STI571 in MBC with expression of CD117 (ckit) and/ or PDGFR by evaluating progression-free survival (PFS). II. To determine the toxicity profile and tolerability of STI571 in patients with MBC. III. To define serum, tissue and imaging surrogate endpoints of activity of STI571 in MBC. OUTLINE: Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given PO
Optional correlative studies
M D Anderson Cancer Center
Houston, Texas, United States
Objective tumor response (CR + PR), as determined by the RECIST criteria
Time frame: Up to 2 years
Incidence of adverse events
Time frame: Up to 2 years
Time to progression
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Time frame: Up to 2 years
Overall survival
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Time frame: Up to 2 years
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