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ACTIVE NOT RECRUITING
NCT02271828
NA

Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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