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New treatment option for Breast Cancer
Official title No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy
ClinicalTrials.gov ID: NCT06704945
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, women only
You may be able to join if
- 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:
- HER2-positive or triple-negative breast cancer (TNBC).
You likely can't join if
- 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.
See the full eligibility 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:
- 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).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.