Conditions: Breast Cancer
Keywords: stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer male breast cancer recurrent breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.

Interventions: intervention 1: capecitabine intervention 2: adjuvant therapy intervention 3: radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: