A Phase III Trial For Patients With Metastatic Breast Cancer

Exclusion Criteria

• •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
• •Parenchymal or leptomeningeal brain metastases
• •Peripheral neuropathy greater than or equal to grade 2
• •Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
• •Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
• •Concomitant Herceptin is not allowed