Topic: National Cancer Research Network
Conditions
Interventions
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
Sponsors
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Eligibility
Sex/Gender
Female
Inclusion criteria
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 psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 8. No metastatic disease (routine investigations are not required: symptoms should be investigated on indication) 9. No previous treatment of the axilla by surgery or radiotherapy 10. No previous treatment of cancer, except Basal Cell Carcinoma of the skin and in situ carcinoma of the cervix 11. No pregnancy
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axillary recurrence rate after 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed