Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: capecitabine; adjuvant therapy; radiation therapy
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; male breast cancer; recurrent breast cancer

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.
    

Eligibility criteria:

        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