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

Study acronym: Neo-NAUTILUS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 31, 2025 to Jun 4, 2025v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 31, 2025 to Jun 4, 2025
  2. Start date: Dec 15, 2024 to Mar 31, 2025 Enrollment target: 604 to 464v3 Show 1 more changeShow less
    • Enrollment target: 604 to 464
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06704945
Lead Sponsor Seoul National University Hospital
Collaborators: Asan Medical Center
Conditions Breast Cancer, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy
Enrollment 464 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov