NCT00045188

Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

Phase II Trial of STI571 in Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given PO
OTHER	laboratory biomarker analysis	Optional correlative studies

Timeline

• Start date: 2002-08-01
• Primary completion: 2004-07-01
• First posted: 2003-01-27
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States