Clinical Trial

A Prospective Multicenter Study of the TuFEst-LN Model for Axillary Lymph Node Status Assessment in Breast Cancer

Study acronym: PRO-TuFEst-LN
Recruiting
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Summary
Through the research of this project, we expect to validate the clinical utility of the TuFEst-LN model in assessing axillary lymph node status in breast cancer patients. Specifically, we aim to prospectively validate its ability to identify pathologically node-negative patients among clinically and radiologically assessed cN0 patients undergoing upfront surgery ，and explore the predictive value of the TuFEst-LN model combined with preoperative MRI for ypN status assessment in initially node-positive patients following neoadjuvant therapy.
Protocol Amendment History 4 changes
critical Recruitment opened 2026-08-11
critical Primary endpoint(s) modified 2026-08-11
notable Enrollment increased: 269 -> 400 participants 2026-08-11
notable Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University -> Second Affiliated Hospital, Zhejiang University, School of Medicine 2026-08-09
Trial Details
NCT Number NCT07304934
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators: Shandong Cancer Hospital and Institute, Suzhou Municipal Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, First People's Hospital of Hangzhou, Ningbo Medical Center Lihuili Hospital
Conditions Breast Cancer, Axillary Lymph Node Metastasis
Enrollment 400 participants
Start Date 2025-08-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10