S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed stage IV breast cancer
• * Metastatic disease (M1) OR multiple sites of new disease that is clinically obvious metastatic disease (i.e., multiple sites of new osseous disease)
• Meets 1 of the following criteria:
• * Measurable disease
• * Non-measurable disease
• * MUC-1 antigen level \> 2 times upper limit of normal AND level has increased by 1.5 times
• Must have documented MUC-1 antigen level
• * Either cancer antigen (CA) 15-3 or CA 27-29 allowed
• Must have received at least 1 prior hormonal therapy for metastatic disease (estogen receptor-positive patients only)
• No symptomatic brain or CNS metastases
• * Previously treated brain or CNS metastasis allowed provided radiotherapy was completed ≥ 8 weeks before study entry
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• Zubrod 0-2
• Life expectancy
• Not specified
• Hematopoietic
• No known existing uncontrolled coagulopathy
• Hepatic
• Not specified
• Renal
• Creatinine clearance \> 40 mL/min
• Cardiovascular
• No congestive heart failure
• No symptomatic coronary artery disease
• No cardiac arrhythmia not well controlled with medication
• No myocardial infarction within the past 12 months
• No other clinically significant cardiac disease
• Gastrointestinal
• Able to take oral medication
• No uncontrolled nausea, vomiting, or diarrhea
• No lack of physical integrity of the upper gastrointestinal tract
• No malabsorption syndrome
• Other
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No active infection requiring systemic therapy
• No prior severe reaction to fluoropyrimidines
• No known sensitivity to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent immunotherapy or biologic therapy for breast cancer
• No concurrent gene therapy for breast cancer
• No concurrent filgrastim (G-CSF)
• Chemotherapy
• At least 14 days since prior chemotherapy and recovered
• No more than 2 prior chemotherapy regimens for metastatic disease
• No prior capecitabine for metastatic disease
• No prior oral cyclophosphamide for metastatic disease
• * Prior IV cyclophosphamide allowed
• No other concurrent chemotherapy for breast cancer
• Endocrine therapy
• See Disease Characteristics
• No concurrent hormonal therapy for breast cancer
• Radiotherapy
• See Disease Characteristics
• At least 14 days since prior radiotherapy to non-CNS disease sites and recovered
• No concurrent radiotherapy for breast cancer
• Surgery
• Not specified
• Other
• Concurrent bisphosphonates allowed
• No concurrent full-dose warfarin
• * Concurrent prophylactic warfarin (≤ 1 mg/day) to maintain port patency allowed
• No other concurrent antineoplastic therapy for breast cancer