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

NCT06704945 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2026-01-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

No axillary surgery

BCS only. Ommission of axillary surgery. No axillary surgery after neoadjuvant chemotherapy.

PROCEDURE

Axillary surgery

BCS with SLNB(+/-ALND)

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-04
Primary Completion
2029-12-31
Completion
2034-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704945 on ClinicalTrials.gov