Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy
- Measurable or evaluable disease
- Females > 18 years
- Able to perform activities of daily living with minimal assistance
- Life expectancy > 3 months
- Adequate bone marrow, liver and kidney function
- All patients must give written informed consent in order to participate.
You cannot participate in this study if any of the following apply to you:
- Women who are pregnant or lactating.
- Received more than 3 prior chemotherapy regimens in the metastatic setting.
- Received continuous infusion 5-fluorouracil lasting > 120 hours.
- Received thalidomide or capecitabine as their last prior regimen.
- Preexisting moderate to severe neuropathy
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.