NCT06704945 (Neo-NAUTILUS) is a Phase 3 clinical trial of No axillary surgery in Breast Cancer, sponsored by Seoul National University Hospital.

Who is sponsoring NCT06704945?

NCT06704945 is sponsored by Seoul National University Hospital.

What drugs are being tested in NCT06704945?

Interventions in NCT06704945: No axillary surgery, Axillary surgery.

What condition does NCT06704945 study?

NCT06704945 studies Breast Cancer, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy.

Is NCT06704945 still recruiting?

NCT06704945 is currently recruiting now. Last updated 28 January 2026.

Last reviewed 2026-01-28 · How we verify

NCT06704945: Neo-NAUTILUS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 28 January 2026

What this trial tests

Phase 3 trial testing No axillary surgery in Breast Cancer in 464 participants. Currently enrolling.

Timeline

4 June 2025

Primary endpoint
31 December 2029

31 December 2034

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	464
Start date	4 June 2025
Primary completion	31 December 2029
Estimated completion	31 December 2034
Sites	1 location across South Korea

Drugs / interventions tested

No axillary surgery
Axillary surgery

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →
Sentinel Lymph Node Biopsy — all drugs for Sentinel Lymph Node Biopsy →

Sponsor

Seoul National University Hospital

Who can join

19 and older, female only, with Breast Cancer or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Omission of Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: Expanding Evidence in Clinically Node-Negative and Neoadjuvant Therapy Responders.
Grapes A, Young J, Takabe K. · · 2026 · PMID 42147263 · DOI 10.14740/wjon2776
Primary tumour response on breast MRI as a predictor of axillary pathologic response in breast cancer patients treated with neoadjuvant chemotherapy.
van Amstel FJG, van Mierlo RGM, Nelemans PJ, Engelen SME, et al · · 2026 · PMID 41436643 · DOI 10.1007/s00330-025-12249-x
A Randomized Trial of Sentinel Node Biopsy Omission After Neoadjuvant Systemic Therapy in Clinically Node-Negative or Selected Node-Positive Breast Cancer.
Jung JJ, Kim HJ, Chae BJ, Kim EK, et al · · 2025 · PMID 41311332 · DOI 10.4048/jbc.2025.0157

Verify or expand the search:

Other trials of No axillary surgery

Trials testing the same drug.

NCT05315154 — Sentinel Lymph Node Biopsy Versus No Axillary Surgery in Early Breast Cancer · NA · recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Seoul National University Hospital trials

Trials by the same sponsor.

NCT07262944 — EOI Block in Otoplasty With Rib Cartilage Graft · NA · recruiting
NCT07464210 — Nemtabrutinib, Bortezomib, and Rituximab for WM · Phase 2 · not yet recruiting
NCT07550803 — Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery · NA · not yet recruiting
NCT07522138 — Home-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study · NA · not yet recruiting
NCT07476651 — Scout Dose of Resin Microspheres · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06704945 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seoul National University Hospital
Last refreshed: 28 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06704945.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing