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ACTIVE NOT RECRUITING
NCT04303715
NA

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Official title: No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography[NAUTILUS]: A Prospective, Multicenter, Phase III Clinical Trial

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1734

Start Date

2020-09-15

Completion Date

2027-12-31

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

PROCEDURE

No SLNB

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

PROCEDURE

SLNB

BCS with SLNB(+/-ALND)

Locations (1)

Seoul National University Hospital

Seoul, Seoul, South Korea