Capecitabine in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
• •* Evidence of metastatic involvement (stage IV disease)
• •Patients must have measurable disease
• •* At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
• •Treated brain metastases (surgery or radiation therapy) allowed if clinically stable
• •Patients with leptomeningeal disease are ineligible
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• •Male or female
• •Menopausal status not specified
• •Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Creatinine clearance \> 50 mL/min
• •Fertile patients must use effective contraception
• •No history of another severe and/or life-threatening medical disease
• •No other active primary malignancy
• •Not pregnant or nursing
• •Negative pregnancy test
• •Patients with asymptomatic HIV infection are eligible
• •Liver dysfunction score ≤ 9
• •No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)
• •No active gastrointestinal malabsorption illness
• •No clinically significant cardiac disease, including the following:
• •* Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months
• •No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency
• •No history of uncontrolled seizures or central nervous system disorders
• •No significant history of noncompliance to medical regimens
• •No clinically significant psychiatric disability that would preclude study compliance
• •PRIOR CONCURRENT THERAPY:
• •No previous capecitabine
• •Up to 3 prior cytotoxic regimens allowed for metastatic disease
• •* Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)
• •No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy
• •No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy
• •No other concurrent investigational drugs
• •No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)
• •* Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
• •At least 4 weeks since prior sorivudine or brivudine
• •Concurrent use of bisphosphonates allowed if initiated before beginning study therapy
• •Concurrent use of megestrol acetate suspension as an appetite stimulant allowed