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

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