No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No axillary surgery, Axillary surgery.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy: A Prospective, Phase III Clinical Trial
Overview
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.
Detailed description
Background:
* No prospective studies have proven that axillary lymph node surgery improves survival in breast cancer patients. * The ACOSOG Z0011 trial showed that additional axillary dissection did not improve recurrence or survival, even with a 23.7% incidence of non-sentinel node metastases. * NSABP B-32 established the oncologic safety of SLNB, significantly reducing complications like lymphedema compared to axillary dissection. However, SLNB still carries risks of lymphedema, sensory changes, seromas, and infections. * The trend has now shifted toward identifying candidates for omitting axillary surgery to minimize unnecessary complications. * The SOUND trial demonstrated non-inferiority of omitting SLNB in early-stage breast cancer patients with negative axillary ultrasound. Five-year distant metastasis-free survival was comparable between SLNB and no-SLNB groups (97.7% vs. 98.0%). * Improved ultrasound accuracy (e.g., FNR: 13.7% in SOUND; 11.3% in NAUTILUS) and the therapeutic contribution of whole-breast radiation likely support these findings. * Patients with a complete pathological response (pCR) in the breast post-NAC rarely have residual lymph node metastases, reducing the need for axillary surgery. * Single-arm studies (e.g., EUBREAST-01, ASICS, ASLAN) have explored omitting axillary surgery in patients with confirmed breast pCR. However, these studies face limitations due to small sample sizes, single-arm design, and the necessity of axillary surgery if pCR is not achieved. * To address these limitations, the NEO-NAUTILUS trial proposes the first randomized trial to compare disease-free survival and local recurrence rates between patients who omit SLNB (experimental group) and those who undergo SLNB (control group) after NAC, focusing on patients deemed axillary node-negative by ultrasound.
Interventions
- Procedure No axillary surgery
BCS only. Ommission of axillary surgery. No axillary surgery after neoadjuvant chemotherapy. - Procedure Axillary surgery
BCS with SLNB(+/-ALND)
Primary outcome measures
- Invasive Disease Free Survival (iDFS) [Time frame: 5 years]
Secondary outcome measures (5)
- Overall Survival (OS) [Time frame: 5 years]
- Distant Metastasis Free Survival (DMFS) [Time frame: 5 years]
- Axillary recurrence rate [Time frame: 5 years]
- Locoregional Recurrence Rate (LRR) [Time frame: 5 years]
- QoL [Time frame: 1 year]
Eligibility criteria
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:
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hopsital — Seoul
Publications
- 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 35184724
- 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 41311332
Identifiers
NCT: NCT06704945 · H-2410-138-1581