Clinical trial · Interventional
No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography
No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography[NAUTILUS]: A Prospective, Multicenter, Phase III Clinical Trial
- 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)
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.
Conditions
Conditions (2)
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 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No SLNB | Procedure | — | UNRESOLVED |
| SLNB | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- No SLNB group
- description
- The study arm - BCS without SLNB
- interventionNames
- Procedure: No SLNB
- type
- OTHER
- label
- SLNB group
- description
- The Control Arm - BCS with SLNB(+/-ALND)
- interventionNames
- Procedure: SLNB
Primary outcomes (1)
- measure
- Disease Free Survival (DFS)
- timeFrame
- 5 years
- description
- Evaluate disease free survivals
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDRyu 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 Apr;52(4):111458. doi: 10.1016/j.ejso.2026.111458. Epub 2026 Feb 2. PMID 41689946
- DERIVEDJung 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
- DERIVEDChang 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 34877830