Actively Recruiting
No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
Led by Seoul National University Hospital · Updated on 2026-01-28
464
Participants Needed
1
Research Sites
499 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
A
Asan Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 6519 years
- Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy
- Clinical staging before chemotherapy: cT1-3, cN0, M0 (AJCC 8th Edition)
- For pre-chemotherapy staging cT1-3, cN1, M0, must have HER2-positive or triple-negative breast cancer and at least 30% tumor size reduction on MRI after chemotherapy
- Negative axillary lymph node status on ultrasound after chemotherapy
- Planned breast-conserving surgery with at least half of the planned neoadjuvant chemotherapy completed
- ECOG performance status of 0 to 2
- Signed informed consent before joining the study
You will not qualify if you...
- History of any cancer within the past 5 years
- Bilateral breast cancer
- Requirement for mastectomy
- Tumor size greater than 5 cm after chemotherapy
- Male breast cancer
- Pregnant or breastfeeding women
- Inability to understand and complete questionnaires
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hopsital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
W
Wonshik Han, MD, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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