Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Safety And Feasibility Study Of Concurrent Capecitabine (Xeloda) And External Beam Irradiation In The Adjuvant Treatment Of High Risk Early Stage Breast Cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed invasive adenocarcinoma of the breast, meeting 1 of the following high-risk criteria: T3 or T4 primary tumor 4 or more involved axillary lymph nodes (N2 nodal stage) Completed surgical excision No immediate reconstruction with autologous flap reconstruction Patients having tissue expanders or implants placed prior to radiation may be enrolled at the physician's discretion No residual breast cancer Microscopically positive margins are allowed if a re-excision is not felt to be clinically justified Candidate for radiotherapy Must not require bilateral radiotherapy No metastatic (stage IV) breast cancer by AJCC staging criteria Hormone receptor status not specified No CNS disorders PATIENT CHARACTERISTICS: Life expectancy ≥ 6 months Karnofsky performance status 70-100% Menopausal status not specified Ambulatory Hemoglobin > 9 g/dL Platelet count > 100,000/mm³ ANC > 1,500/mm³ Serum AST, ALT, and alkaline phosphatase ≤ 2 times upper limit of normal (ULN) Total bilirubin normal Creatinine clearance > 50 mL/min Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception during study and for 30 days after the last study drug administration No serious, uncontrolled, concurrent infection(s) No diabetes with current or history of delayed wound healing or skin ulcers No autoimmune connective tissue disorder No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency No other carcinomas within the last five years except cured non-melanoma skin cancer and in-situ cervical cancer No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months No other serious uncontrolled medical conditions that the investigator feels might compromise study participation, including any of the following: Uncontrolled seizures Psychiatric disability judged by the investigator to be clinically significant Physically intact upper gastrointestinal tract No malabsorption syndrome No uncompensated coagulopathy No patients whose breast size or body contour puts them at increased risk for skin desquamation from standard radiotherapy Able to read and speak English PRIOR CONCURRENT THERAPY: Fully recovered from surgery and chemotherapy with completely healed surgical wounds At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab (Herceptin®) Concurrent trastuzumab allowed at the physician's discretion More than 4 weeks since prior participation in any investigational drug study At least 4 weeks since prior and no concurrent sorivudine or brivudine More than 2 weeks since prior major surgery No prior capecitabine No prior radiotherapy to the chest or ipsilateral lymphatics No concurrent hormonal therapy during course of chemotherapy or radiation therapy No concurrent allopurinol or cimetidine Concurrent coumadin is allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery and Chemotherapy<br>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. | Drug: capecitabine<br> <br> Procedure: adjuvant therapy<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety | Primarily Grade 1 and 2 toxicities attributable to capecitabine | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmesis |  | 1 year | 
| Recurrence | This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, male breast cancer, recurrent breast cancer