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

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 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.

Conditions4

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