After mapping of the axilla: radiotherapy or surgery

Phase 3

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast; Cancer; Breast cancer

• Registration Number: ISRCTN13672866
• Lead Sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Brief Summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23522754 (added 10/09/2019) 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25439688 2015 results (Dutch) in: https://www.ncbi.nlm.nih.gov/pubmed/26488192 (added 10/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-29
• Study Completion: 2010-05-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

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

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified