Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Aventis Pharmaceuticals; Novartis
• Treatments: Docetaxel; Imatinib Mesylate

Criteria

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.