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No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy

RecruitingPhase 3Ages 19 Years - anyFemaleSeoul National University Hospital
NCT06704945 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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: 1. HER2-positive or triple-negative breast cancer (TNBC). 2. 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.
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What it tests

  • No axillary surgery
  • Axillary surgery
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Where

1 site
Seoul National University Hopsital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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