NCT04303715

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,734

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
20mo left

Started Sep 2020

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2020Dec 2027

First Submitted

Initial submission to the registry

March 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 13, 2026

Status Verified

September 1, 2025

Enrollment Period

7.3 years

First QC Date

March 8, 2020

Last Update Submit

February 11, 2026

Conditions

Breast CancerSentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival (DFS)

    Evaluate disease free survivals

    5 years

Secondary Outcomes (6)

  • Overall Survival (OS)

    5 years

  • Distant Metastasis Free Survival (DMFS)

    5 years

  • Axillary recurrence rate

    5 years

  • Locoregional Recurrence Rate (LRR)

    5 years

  • Patient reported Adverse Events (AEs)

    1 year

  • +1 more secondary outcomes

Study Arms (2)

No SLNB group

EXPERIMENTAL

The study arm - BCS without SLNB

Procedure: No SLNB

SLNB group

OTHER

The Control Arm - BCS with SLNB(+/-ALND)

Procedure: SLNB

Interventions

No SLNBPROCEDURE

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

No SLNB group
SLNBPROCEDURE

BCS with SLNB(+/-ALND)

SLNB group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ≥ 19 years
  • Invasive unilateral breast carcinoma with histological confirmation
  • History of invasive breast cancer
  • Histologically or radiologically no suspicion of distant metastases
  • Performance status corresponding to ECOG grade 0-2
  • Tumor size clinically and radiologically ≤ 5cm, independent of hormone receptor and HER2 status
  • Clinically and sonographically negative axillary lymph nodes before biopsy; core needle biopsy or fine needle aspiration of suspicious lymph node required
  • BCS candidate with postoperative whole-breast irradiation and adequate systemic therapy
  • No psychological and geographical restriction in follow-up
  • Written informed consent

You may not qualify if:

  • History of any cancer in the previous 5 years
  • Bilateral breast cancer
  • Invasive breast cancer treated with neoadjuvant therapy
  • Tumor size clinically and radiologically \> 5cm
  • Mastectomy candidate
  • Pregnancy and breastfeeding
  • Male breast cancer
  • Unable to understand and fill out questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Related Publications (3)

  • Ryu JM, Lee HB, Han W, Chung IY, Ahn SH, Lee S, Park S, Jeong J, Lim W, Lee JE, Kang E, Chang JH, Shin KH, Chang JM, Moon WK, Kim EK; NAUTILUS Investigators. Clinicopathologic characteristics and lymph node status in the NAUTILUS clinical trial:KBCSG-21. Eur J Surg Oncol. 2026 Feb 2;52(4):111458. doi: 10.1016/j.ejso.2026.111458. Online ahead of print.

    PMID: 41689946DERIVED

  • Jung JG, Ahn SH, Lee S, Kim EK, Ryu JM, Park S, Lim W, Jung YS, Chung IY, Jeong J, Chang JH, Shin KH, Chang JM, Moon WK, Han W. No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial. BMC Cancer. 2022 Feb 20;22(1):189. doi: 10.1186/s12885-022-09273-1.

    PMID: 35184724DERIVED

  • Chang JM, Shin HJ, Choi JS, Shin SU, Choi BH, Kim MJ, Yoon JH, Chung J, Kim TH, Han BK, Kim HH, Moon WK. Imaging Protocol and Criteria for Evaluation of Axillary Lymph Nodes in the NAUTILUS Trial. J Breast Cancer. 2021 Dec;24(6):554-560. doi: 10.4048/jbc.2021.24.e47. Epub 2021 Nov 24.

    PMID: 34877830DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wonshik Han

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 11, 2020

Study Start

September 15, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 13, 2026

Record last verified: 2025-09

Locations

KR(1)