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

Breast Neoplasms Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02271828
Study type Interventional
Source Maastricht University Medical Center
Contact Marjolein L Smidt, MD, PhD
Phone +31433877477
Status Recruiting
Phase N/A
Start date April 2015
Completion date April 2027
View Details
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