Terminated due to lack of accrual

In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.

Inclusion Criteria:

• must have metastatic breast cancer
• must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
• must have measurable or evaluable disease
• ECOG of 0-1
• patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
• must have adequate organ function
• must be at least 19 years of age
• peripheral neuropathy less than or equal to grade 1
• must have voluntarily signed informed consent
• patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled

Exclusion Criteria:

• patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
• patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
• known uncontrolled existing coagulopathy
• patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
• use of other investigational agents in the last 28 days
• pregnant or lactating women
• patients who are known HIV positive
• patients with life expectancy of less than 3 months
• sexually active patients unwilling to practice reliable contraception during the study