Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

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

Key facts

Study ID

NCT00045188

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2002-08-01

Last updated by the study team

2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed metastatic breast cancer
• Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor
• Adequate tumor tissue from either the primary tumor and/or metastatic disease available for evaluation
• Must have received prior chemotherapy with an anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant or for advanced disease
• At least 1 unidimensionally measurable lesion
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Bone disease may not be only source of measurable disease
• Pleural or peritoneal ascites are not considered measurable disease
• No known brain metastases
• Hormone receptor status:
• Not specified
• Female or male
• Not specified
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 12 weeks
• Absolute neutrophil count at least 1,500/mm\^3
• WBC at least 3,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin normal
• AST or ALT no greater than 2.5 times upper limit of normal
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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