Non-Surgical Treatment in Clinically Lymph Node Negative Patients After Ultrasound: Assessing Disease-Free Survival and Quality of Life

This clinical trial, called NAUTILUS, explores the effectiveness of skipping a common follow-up treatment known as Axillary Lymph Node Dissection (ALND) in patients with breast cancer who have no severe spread to the lymph nodes. The study uses axillary ultrasound to check for the spread of cancer to the lymph nodes. The traditional follow-up treatment, Sentinel Lymph Node Biopsy (SLNB), can lead to side effects like lymphedema, pain, and reduced quality of life. The trial aims to reassess the necessity of SLNB, especially considering advancements in imaging and care. The study focuses on patients in Korea and the Asia-Pacific region, where specific research is needed. In this trial, participants first undergo axillary ultrasound to check for lymph node metastases. If the results are normal, they can join the study. Patients are then randomly assigned to either the study group or the control group. The study group does not receive SLNB, while the control group does. After surgery, all patients receive ipsilateral whole breast radiation. The primary goal is to evaluate the disease-free survival after 5 years. Secondary goals include measuring overall survival, distant metastasis-free survival, axillary recurrence rate, patient-reported side effects, and quality of life.