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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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with primary invasive breast cancer clinical stage II-III

• Palpable or non-palpable axillary metastases visible by ultrasound (other imaging accepted if confirmatory ultrasound is performed) and confirmed by fine needle aspiration or core biopsy

• Written informed consent

• Age ≥ 18 years

Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Sweden
Skåne University Hospital
RECRUITING
Malmö
Örebro University Hospital
RECRUITING
Örebro
Contact Information
Primary
Jana de Boniface, Professor
jana.de-boniface@ki.se
+46702472305
Time Frame
Start Date: 2026-05-13
Estimated Completion Date: 2041-12-31
Participants
Target number of participants: 1380
Treatments
Active_comparator: Axillary lymph node dissection
Axillary lymph node dissection
Experimental: Targeted axillary dissection
Removal of the marked metastasis/-es and a sentinel lymph node biopsy
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov