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
women 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 women with metastatic breast
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.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast cancer
Bidimensionally measurable disease Hormone receptor status: 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
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