STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate. HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,644
Sentinel lymph node procedure according to the Dutch breast cancer guideline
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia ziekenhuis
Breda, Netherlands
Deventer ziekenhuis
Deventer, Netherlands
Catharina ziekenhuis
Eindhoven, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Groene Hart ziekenhuis
Gouda, Netherlands
...and 12 more locations
Regional recurrence rate
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
Time frame: Up to ten years
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