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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Nov 21, 2024

Keywords

ClinConnect Summary

The NEO-NAUTILUS clinical trial is studying whether women with breast cancer, who have clinically negative lymph nodes after receiving neoadjuvant chemotherapy, can safely skip surgery to remove lymph nodes in the armpit (known as axillary lymph node surgery) without affecting their chances of staying cancer-free over five years. This trial is important because it may help simplify treatment for women with specific types of breast cancer and could reduce the need for additional surgeries.

To participate in this trial, women must be at least 19 years old and have been diagnosed with invasive breast cancer that has been treated with neoadjuvant chemotherapy. They should have specific characteristics such as having no cancer found in the lymph nodes after treatment and being planned for breast-conserving surgery. Participants will undergo regular check-ups to monitor their health and response to treatment. It’s important to note that this trial is not yet recruiting, so interested individuals should stay tuned for updates on how to enroll.

Gender

FEMALE

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.