No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy

NEO-NAUTILUS is a prospective, multicenter, randomized phase III clinical trial to evaluate whether omitting axillary lymph node surgery (ALND or SLNB) in clinically lymph node-negative breast cancer patients after neoadjuvant chemotherapy is non-inferior to performing SLNB in terms of 5-year disease-free survival.

NCT Number	NCT06704945
Lead Sponsor	Seoul National University Hospital Collaborators: Asan Medical Center
Conditions	Breast Cancer, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy
Enrollment	464 participants
Start Date	2025-06-04
Primary Completion	2029-12-31 (estimated)
Study Completion	2034-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-28