No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial.
Ji Gwang Jung, Se Hyun Ahn, Seeyoun Lee...
https://pubmed.ncbi.nlm.nih.gov/35184724Actively Recruiting
Phase 3
Age: 19Years +
FEMALE
ID06704945
No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy: A Prospective, Phase III Clinical Trial
Led by Seoul National University Hospital · Updated on 2026-01-28
464
Participants Needed
1
Research Sites
260 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
Researchers are evaluating whether skipping axillary lymph node surgery after neoadjuvant chemotherapy is as safe as performing sentinel lymph node biopsy (SLNB) in breast cancer patients who show no lymph node involvement on ultrasound. This phase III trial aims to understand if avoiding axillary surgery affects 5-year disease-free survival, building on previous studies that suggest some patients may not need this surgery to reduce complications without compromising outcomes. Participants will be randomly assigned to one of two groups. One group will have breast-conserving surgery (BCS) without any axillary surgery, while the other group will have BCS with SLNB, possibly including axillary lymph node dissection (ALND). The study compares these approaches after patients complete neoadjuvant chemotherapy and shows no lymph node involvement on ultrasound. During the trial, participants will be monitored over five years for invasive disease-free survival, overall survival, distant metastasis-free survival, and rates of axillary and locoregional recurrence. Quality of life will also be assessed for one year. The study involves regular clinical evaluations, imaging, and questionnaires to track outcomes and safety, with the goal of minimizing unnecessary surgical procedures and related complications.
CONDITIONS
Brief Title
No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
Who Can Participate
Age: 19Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 19 years or older
- Histologically confirmed invasive breast cancer treated with neoadjuvant chemotherapy
- Clinical staging prior to chemotherapy: cT1-3, cN0, M0
- For cT1-3, cN1, M0 staging before chemotherapy, must be HER2-positive or triple-negative breast cancer and show at least 30% tumor size reduction on MRI after chemotherapy
- Negative axillary lymph node status on ultrasound after chemotherapy
- Planned for breast-conserving surgery with at least half of planned neoadjuvant chemotherapy completed
- ECOG performance status of 0 to 2
- Signed informed consent before enrollment
You will not qualify if you...
- History of any cancer within the past 5 years
- Bilateral breast cancer
- Patients requiring mastectomy
- Tumor size larger than 5 cm after chemotherapy
- Male breast cancer
- Pregnant or breastfeeding women
- Inability to understand and complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single surgical treatment after completion of chemotherapy
Participants receive breast-conserving surgery (BCS) after neoadjuvant chemotherapy, either without axillary surgery (experimental group) or with sentinel lymph node biopsy (SLNB) with or without axillary lymph node dissection (ALND) (control group).
1 surgical visit
Follow-up
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess disease-free survival, overall survival, recurrence rates, and quality of life.
Regular visits over 5 years (specific schedule not defined)
Trial Site Locations
Total: 1 location
1
Seoul National University Hopsital
Seoul, South Korea, 03080
Actively Recruiting
Loading map...
Research Team
W
Wonshik Han, MD, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
A Randomized Trial of Sentinel Node Biopsy Omission After Neoadjuvant Systemic Therapy in Clinically Node-Negative or Selected Node-Positive Breast Cancer.
Ji-Jung Jung, Hee Jeong Kim, Byung Joo Chae...
https://pubmed.ncbi.nlm.nih.gov/41311332