RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel and capecitabine in treating patients who have metastatic breast cancer.

OBJECTIVES: I. Determine the safety, response rate, and efficacy of combination therapy with paclitaxel and capecitabine as first or second line therapy in patients with metastatic breast cancer.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1 and capecitabine orally twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival status every 3 months upon completion of treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed metastatic breast cancer
• Bidimensionally measurable disease
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Eligible patients may have received prior chemotherapy in metastatic or adjuvant setting with the following exceptions: At least 12 months since prior fluoropyrimidine therapy; At least 12 months since prior taxane therapy; Only 1 previous chemotherapeutic regimen in the metastatic setting
• Endocrine therapy: Not specified
• Radiotherapy: At least 4 weeks since prior radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 to 75
• Sex: Female
• Menopausal status: Not specified
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: ANC at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN)
• Renal: Creatinine less than 1.5 times ULN
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception