Skipping axillary surgery when lymph nodes look normal on ultrasound after preoperative chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NEO-NAUTILUS is a prospective, multicenter, randomized phase III non-inferiority trial comparing omission of axillary lymph node surgery to sentinel lymph node biopsy in patients who are clinically node-negative on ultrasound after neoadjuvant chemotherapy. Participants who completed at least part of a planned NAC regimen and are planned for breast-conserving surgery are randomized to either no axillary surgery or standard sentinel node surgery. The primary endpoint is 5-year disease-free survival, with follow-up to detect recurrences and survival differences between arms. The trial builds on prior de-escalation work (e.g., SOUND, Z0011) and uses contemporary imaging and pathological response data to select patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seoul National University Hopsital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Wonshik Han, MD, PhD.
• Email: hanw@snu.ac.kr
• Phone: 82-2-3461-6060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.