Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Metastatic breast cancer confirmed by biopsy
• No more than one prior chemotherapy regimen for metastatic breast cancer
• Able to perform activities of daily living with minimal assistance
• Adequate bone marrow, liver and kidney function
• Age 18 years or older
• Give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Moderate to severe peripheral neuropathy
• Uncontrolled blood pressure or uncontrolled heart beat irregularities
• Diabetes Mellitus with fasting blood sugar greater than 200 mg %
• Significant heart disease within the prior 6 months
• Severe or uncontrolled medical disease
• Active uncontrolled infection
• Known chronic liver disease
• Known diagnosis of HIV infection
• Pregnant or breast feeding females

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.