Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral cyclophosphamide once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then at weeks 7, 13, 19, and 25.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study within 4 years.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IV breast cancer
Meets 1 of the following criteria:
Measurable disease
Non-measurable disease
Must have documented MUC-1 antigen level
Must have received at least 1 prior hormonal therapy for metastatic disease (estogen receptor-positive patients only)
No symptomatic brain or CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
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
No other concurrent chemotherapy for breast cancer
Endocrine therapy
Radiotherapy
Surgery
Other
Concurrent bisphosphonates allowed
No concurrent full-dose warfarin
No other concurrent antineoplastic therapy for breast cancer
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