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Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
Sponsor: Maastricht University Medical Center
Summary
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.
Official title: Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1644
Start Date
2015-04
Completion Date
2027-07
Last Updated
2025-05-11
Healthy Volunteers
No
Conditions
Interventions
Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline
Locations (22)
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
UMC Groningen
Groningen, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Alrijne
Leiden, Netherlands
St. Antonius ziekenhuis
Nieuwegein, Netherlands
Canisius-Wilhelmina ziekenhuis
Nijmegen, Netherlands
Radboud UMC
Nijmegen, Netherlands
Laurentius ziekenhuis
Roermond, Netherlands
Haga ziekenhuis
The Hague, Netherlands
Diakonessenhuis
Utrecht, Netherlands
UMC Utrecht
Utrecht, Netherlands
Zuwehofpoort ziekenhuis
Woerden, Netherlands
Isala Klinieken
Zwolle, Netherlands