RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine together with radiation therapy works in treating patients with nonmetastatic breast cancer.
OBJECTIVES: Primary * To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer. Secondary * To determine the effects of concurrent treatment on cosmesis and wound healing at 1 year. * To determine the short-term (1-year) risk of recurrence of breast cancer in these patients. OUTLINE: This is a multicenter study. Patients undergo external-beam radiotherapy once daily, 5 days a week and concurrently receive oral capecitabine twice daily, 5 days a week Monday through Friday, for approximately 6-7 weeks. After completion of study therapy, patients are followed at approximately 1 week, 1 month, 6 months, and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Overall Safety
Primarily Grade 1 and 2 toxicities attributable to capecitabine
Time frame: 1 year
Cosmesis
Time frame: 1 year
Recurrence
This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy
Time frame: 1 year
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