• Overall survival [ Time Frame: 13 years ] [ Designated as safety issue: No ]
  Duration of study
  
  

• Disease-free survival (including locoregional and distant disease) [ Time Frame: 13 years ] [ Designated as safety issue: No ]
  Duration of study
  
  
• Toxicity assessed by NCI CTC v2.0 [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  Baseline, last week of radiation treatment, months 3 and 9 after last dose of radiotherapy, then every 6 months for 2 years and then annually.
  
  
• Quality of life assessed by the EORTC QLQ-C30, OCOG Breast Cancer Questionnaire [ Time Frame: annually until distance recurrence ] [ Designated as safety issue: No ]
  Baseline, last week of radiation treatment, 3 and 9 months after last dose of radiotherapy than annually until distance recurrence.
  
  
• Cosmetic outcome according to the EORTC Breast Cancer Rating System for Cosmetic Results of Breast Conserving Treatment [ Time Frame: 33 and 57 months ] [ Designated as safety issue: No ]
  Baseline at 33 months and 57 months post radiotherapy.
  
  

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.