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.
Histologically confirmed invasive breast cancer.
Clinical stage cT1-3, cN0, M0 disease at enrollment.
No clinically palpable suspicious metastatic axillary lymph nodes identified by physical examination.
No radiologically suspicious metastatic axillary lymph nodes identified by preoperative axillary imaging (at least ultrasound examination). Patients with suspicious lymph nodes must have negative cytological or histological findings confirmed by fine-needle aspiration or core needle biopsy.
Pregnancy or breastfeeding.
Prior surgical removal of the primary breast lesion before enrollment, resulting in inability to obtain the required preoperative blood samples.
Presence of confirmed distant metastasis.
Presence of supraclavicular, internal mammary, or other lymph node lesions that cannot be adequately assessed by planned surgery and pathological evaluation.
Second Affiliated Hospital, Zhejiang University, School of Medicine
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborator
Suzhou Municipal Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
First People's Hospital of Hangzhou
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator