Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement

The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology/cytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.

NCT Number	NCT07278726
Lead Sponsor	European Institute of Oncology
Conditions	ALND, Sentinel Lymph Node Biopsy (SLNB), Targeted Axillary Dissection (TAD)
Enrollment	150 participants
Start Date	2026-01-28
Primary Completion	2028-11 (estimated)
Study Completion	2033-11 (estimated)
Updated on ClinicalTrials.gov	2026-06-16