RecruitingNot ApplicableNCT06869629

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

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


Sponsor

Karolinska Institutet

Enrollment

1,380 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Axillary lymph node dissection and a procedure called Targeted axillary dissection for people with breast cancer, breast carcinoma, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETargeted axillary dissection

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

PROCEDUREAxillary lymph node dissection

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


Locations(4)

Helsinki University Hospital

Helsinki, Finland

Samsung Medical Center

Seoul, South Korea

Skåne University Hospital

Malmö, Sweden

Örebro University Hospital

Örebro, Sweden

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NCT06869629


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