EORTC (European Organisation for Research and Treatment of Cancer)
Avenue E. Mounier 83-11 B-1200, Brussels, Belgium
www.eortc.be
Tel +32 2 774 16 11
orta@eortc.be
Randomization: Arm A: complete axillary lymph node dissection Arm B: radiotherapy to the axilla
Objectives
To prove equivalent local/regional control for patients with proven axillary lymph node metastasis by sentinel node biopsy with reduced morbidity if treated with axillary radiotherapy instead of axillary lymph node dissection. A second objective is to investigate whether adequate axillary control can be obtained by notsubjecting patients with a negative sentinel lymph node to axillary lymph node dissection.
Endpoints
Primary endpoint:
Axillary recurrence free rate in the axillary lymph node dissection treatment group at 5 years
Secondary endpoints:
Overall survival
Axillary recurrence free survival
Shoulder function
Quality of life
Eligibility Criteria
T1,2 (> 5 mm and < 50 mm), N0 M0 Age >=18 Pre-and postmenopausal Female patients