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RECRUITING
NCT06704945
PHASE3

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Official title: No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy: A Prospective, Phase III Clinical Trial

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

464

Start Date

2025-06-04

Completion Date

2034-12-31

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

PROCEDURE

No axillary surgery

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

PROCEDURE

Axillary surgery

BCS with SLNB(+/-ALND)

Locations (1)

Seoul National University Hopsital

Seoul, South Korea