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
Seoul National University Hospital
464 participants
Jun 4, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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 Criteria7
- 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.
Interventions
BCS only. Ommission of axillary surgery. No axillary surgery after neoadjuvant chemotherapy.
BCS with SLNB(+/-ALND)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06704945