Stage IV Breast Cancer Clinical Trial
Official title:
Phase II Trial of STI571 in Metastatic Breast Cancer
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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