Breast Cancer Clinical Trial
Official title:
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:
- Determine the response rate (complete and partial, confirmed and unconfirmed) in women
with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine.
- Determine the progression-free survival and overall survival of patients treated with
this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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