NCT06704945 No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
| NCT ID | NCT06704945 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Seoul National University Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 464 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 464 participants in total. It began in 2025-06-04 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06704945 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06704945 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 464 participants.
Is NCT06704945 currently recruiting?
Yes, NCT06704945 is actively recruiting participants. Contact the research team at hanw@snu.ac.kr for enrollment information.
Where is the NCT06704945 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06704945 clinical trial?
NCT06704945 is sponsored by Seoul National University Hospital. The trial plans to enroll 464 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.