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No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography

NCT04303715 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1734

Last updated 2026-02-13

No results posted yet for this study

Summary

NAUTILUS study is a prospective, multicenter, RCT. Clinically T1,T2, node negative BCS candidates with no evidence of metastases in AUS are 1:1 randomized into no SLNB group and SLNB group.

NAUTILUS study aim to establish the minimally invasive treatment of breast cancer by reexamining the necessity of sentinel lymph node biopsy among patients with invasive breast cancer who have tumors under 5cm, are clinically node-negative, and are having breast conserving surgery performed.

Conditions

Interventions

PROCEDURE

No SLNB

BCS only. Ommission of SLNB by axilla ultrasonography among selective breast cancer patients

PROCEDURE

SLNB

BCS with SLNB(+/-ALND)

Sponsors & Collaborators

  • National Evidence-Based Healthcare Collaborating Agency

    collaborator OTHER_GOV

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Wonshik Han · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2027-12-31
Completion
2027-12-31

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 NCT04303715 on ClinicalTrials.gov