NCT06704945

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
464

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
106mo left

Started Jun 2025

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
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 Progress10%
Jun 2025Dec 2034

First Submitted

Initial submission to the registry

November 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

June 4, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

4.6 years

First QC Date

November 21, 2024

Last Update Submit

January 26, 2026

Conditions

Breast CancerNeoadjuvant TherapySentinel Lymph Node Biopsy

Keywords

Omission of axillary surgery after neoadjuvant chemotherapyBreast cancerNeoadjuvant chemotherapyDe-escalationOmission of surgery

Outcome Measures

Primary Outcomes (1)

  • Invasive Disease Free Survival (iDFS)

    Evaluate invasive disease free survivals

    5 years

Secondary Outcomes (5)

  • Overall Survival (OS)

    5 years

  • Distant Metastasis Free Survival (DMFS)

    5 years

  • Axillary recurrence rate

    5 years

  • Locoregional Recurrence Rate (LRR)

    5 years

  • QoL

    1 year

Study Arms (2)

No SLNB group

EXPERIMENTAL

The study arm - BCS without SLNB

Procedure: No axillary surgery

SLNB group

OTHER

The control arm - BCS with SLNB(+/-ALND)

Procedure: Axillary surgery

Interventions

No axillary surgeryPROCEDURE

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

No SLNB group
Axillary surgeryPROCEDURE

BCS with SLNB(+/-ALND)

SLNB group

Eligibility Criteria

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

You may qualify if:

  • Women aged ≥19 years.
  • Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy.
  • Clinical staging prior to NAC: cT1-3, cN0, M0 (AJCC 8th Edition).
  • If pre-NAC staging is cT1-3, cN1, M0, must meet the following criteria:
  • HER2-positive or triple-negative breast cancer (TNBC).
  • At least 30% reduction in tumor size on MRI after NAC (comparing pre- and post-NAC MRI).
  • Negative axillary lymph node status on ultrasound after NAC.
  • Planned for breast-conserving surgery with completed neoadjuvant chemotherapy (at least half the planned regimen must be completed).
  • ECOG performance status of 0-2.
  • Signed written informed consent before enrollment.

You may not qualify if:

  • History of any cancer within the past 5 years.
  • Bilateral breast cancer.
  • Patients requiring mastectomy.
  • Tumor size \>5 cm after NAC.
  • Male breast cancer.
  • Pregnant or breastfeeding women.
  • Inability to understand and complete questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hopsital

Seoul, 03080, South Korea

RECRUITING

Related Publications (2)

  • 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: 35184724BACKGROUND

  • Jung JJ, Kim HJ, Chae BJ, Kim EK, Ahn JH, Jeong J, Lee S, Jung SP, Woo J, Min J, Cheun JH, Chung MS, Shin KH, Chang JM, Moon WK, Han W. A Randomized Trial of Sentinel Node Biopsy Omission After Neoadjuvant Systemic Therapy in Clinically Node-Negative or Selected Node-Positive Breast Cancer. J Breast Cancer. 2025 Dec;28(6):437-447. doi: 10.4048/jbc.2025.0157. Epub 2025 Nov 14.

    PMID: 41311332DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Wonshik Han, MD, PhD.

CONTACT

82-2-3461-6060hanw@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 26, 2024

Study Start

June 4, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2034

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Study protocol will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
The study protocol will be published as a journal article.
Access Criteria
Anyone interested in viewing the study protocol will be able to access it through the published journal.

Locations

KR(1)