Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer

Inclusion Criteria

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