A Phase III Trial For Patients With Metastatic Breast Cancer

Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

Inclusion Criteria:

• Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
• Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
• Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
• Patients must have either measurable or non-measurable (evaluable) disease
• Prior radiation therapy allowed of less than 25% of the bone marrow

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