No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
Recruiting
Phase 3
Interventional Study
Breast Cancer
Neoadjuvant Therapy
Sentinel Lymph Node Biopsy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 464 (estimated)
- Sponsor
- Seoul National University Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 o…
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