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.
Women aged ≥19 years.
Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy.
Clinical staging prior to NAC: cT1-3, cN0, M0 (AJCC 8th Edition).
HER2-positive or triple-negative breast cancer (TNBC).
History of any cancer within the past 5 years.
Bilateral breast cancer.
Patients requiring mastectomy.
Tumor size >5 cm after NAC.
Seoul National University Hospital
Lead sponsor
Asan Medical Center
Collaborator