NCT02271828

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

Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,644 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Sentinel lymph node procedure	Sentinel lymph node procedure according to the Dutch breast cancer guideline

Timeline

• Start date: 2015-04-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2014-10-22
• Last updated: 2025-05-11

Locations

22 sites across 1 country: Netherlands