After mapping of the axilla: radiotherapy or surgery

INTERVENTION: Patients will be stratified by institution and will be randomised between complete axillary lymph node dissection and radiotherapy of the axilla. Follow up length: 5 years Study entry: single randomisation only CONDITION: Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast ; Cancer ; Breast cancer PRIMARY OUTCOME: Axillary recurrence rate after 5 years. SECONDARY OUTCOME: 1. Shoulder function analysis; 2. Quality of life; 3. Arm circumference; ; Node positive patients have annual examination and mammograms for 10 years. Quality of life questionnaire, arm circumference and shoulder function measurements measured at 1, 2, 3, 5 and 10 years. INCLUSION CRITERIA: 1. Invasive breast cancer proven by core biopsy or 'triple diagnosis': clinical palpation concordant with malignancy, imaging (mammography or ultrasound) and tumour positive FNA cytology; diagnosis by excisional tumourectomy is allowed. Clinically occult invasive cancer should be proven by histology. 2. Tumour larger than 5 and smaller than 30 mm in its largest diameter, measured by mammography or ultrasound, only one tumour site (palpation, mammogram or ultrasound) in one breast: bilateral unifocal invasive breast cancer is allowed, (bilateral mammogram is mandatory) 3. Clinically negative axillary lymph nodes 4. Patient has to be fit to undergo any of the following treatments: SN‐biopsy, axillary clearance, breast surgery, radiation therapy of the axilla 5. Before patient registration/randomisation, informed consent must be obtained according to ICH/EU GCP, and national/local regulations 6. Female, all ages considered 7. Absence of any psychologi