Clinical trial · Interventional
No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy: A Prospective, Phase III Clinical Trial
NCT06704945CI-TRIAL-00101761Neo-NAUTILUSrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary surgery | Procedure | — | UNRESOLVED |
| No axillary surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- No SLNB group
- description
- The study arm - BCS without SLNB
- interventionNames
- Procedure: No axillary surgery
- type
- OTHER
- label
- SLNB group
- description
- The control arm - BCS with SLNB(+/-ALND)
- interventionNames
- Procedure: Axillary surgery
Primary outcomes (1)
- measure
- Invasive Disease Free Survival (iDFS)
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. HER2-positive or triple-negative breast cancer (TNBC). 2. 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. Exclusion Criteria: * 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.
References
Publications (2)
- BACKGROUNDJung 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 35184724
- DERIVEDJung 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 41311332