RecruitingPhase 3

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

South Korea464 participantsStarted 2025-06-04

Plain-language 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.

Who can participate

Age range19 Years

SexFEMALE

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Inclusion 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).

What they're measuring

Invasive Disease Free Survival (iDFS)

Timeframe: 5 years

Trial details

NCT IDNCT06704945

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Wonshik Han, MD, PhD.

82-2-3461-6060 hanw@snu.ac.kr

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