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NOT YET RECRUITING
NCT06869629
NA

Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

SENOMAC-ULTRA enrols patients who are planned for upfront surgery for a breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. In this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. More extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. This trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node/s in the armpit (the sentinel lymph node/s) and the known metastatic lymph nodes (targeted axillary dissection, TAD), offers non-inferior survival outcomes to a full axillary lymph node dissection.

Official title: SENOMAC-ULTRA: A Prospective Randomised Trial on the Omission of Axillary Lymph Node Dissection in Ultrasound-detectable Axillary Metastases in Primary Breast Cancer Treated by Upfront Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1380

Start Date

2026-01-01

Completion Date

2040-12-31

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

PROCEDURE

Targeted axillary dissection

Known metastases are marked before surgery and removed together with a sentinel lymph node biopsy

PROCEDURE

Axillary lymph node dissection

Routine axillary clearance removing about 10+ lymph nodes from axillary levels I and II