No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
Recruiting · NCT06704945 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Axillary surgeryNo axillary surgery
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.
Who can take part
Age range
19 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Seoul National University Hopsital - Seoul, South Korea