STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate. HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Completion axillary treatment according to the Dutch breast cancer guideline
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia ziekenhuis
Breda, Netherlands
Reinier de Graaf
Delft, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
...and 21 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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