Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the
      tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation
      therapy to the breast alone following surgery is more effective than radiation therapy to the
      breast plus surrounding tissue in treating invasive breast cancer.

      PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to
      see how well it works compared to radiation therapy to the breast plus surrounding tissue in
      treating women who have undergone surgery for early-stage invasive breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall survival, disease-free survival, isolated local regional
           disease-free survival, and distant disease-free survival in women with previously
           resected, early stage, invasive breast cancer treated with breast radiotherapy with or
           without regional radiotherapy.

        -  Compare the toxic effects of these regimens in these patients.

        -  Compare the quality of life of patients (in certain participating centers) treated with
           these regimens.

        -  Compare the cosmetic outcomes in patients (in certain participating centers) treated
           with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number
      of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (<10, > or
      equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal
      therapy (yes vs no), number of axillary lymph nodes excised*, and participating center.
      Patients are randomized to one of two treatment arms.

      NOTE: * Patients with a negative sentinel node dissection with or without an axillary
      dissection will be stratified according to the total number of nodes removed

        -  Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in
           the absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in
           the absence of disease progression or unacceptable toxicity.

      Radiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must
      begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is
      administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and
      fluorouracil [CMF]), or within 16 weeks after the last breast surgery for patients treated
      with hormonal therapy alone.

      Quality of life is assessed (in patients in certain participating centers) within 2 weeks
      prior to randomization, during the last week of radiotherapy, at 3 and 9 months after
      completion of radiotherapy, and then annually until first distant disease recurrence.

      Cosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks
      prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until
      first distant disease recurrence.

      Patients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually
      thereafter.

      PROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within
      approximately 4 years.
    

Intervention name(s): Standard Breast Irradiation; Breast Radiation plus Regional Radiation
Intervention type(s): Radiation; Radiation
Intervention description(s): Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.; Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer