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

NCT02271828 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1644

Last updated 2025-05-11

No results posted yet for this study

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

PROCEDURE

Sentinel lymph node procedure

Sentinel lymph node procedure according to the Dutch breast cancer guideline

Sponsors & Collaborators

  • Borstkanker Onderzoek Groep

    collaborator NETWORK

  • Dutch Cancer Society

    collaborator OTHER

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marjolein L Smidt, MD, PhD · Maastricht University Medical Centre, Maastricht, the Netherlands

  • Hans JW de Wilt, MD, PhD · Radboud University Medical Centre, Nijmegen, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02271828 on ClinicalTrials.gov