This prospective observational diagnostic study aims to evaluate the feasibility of using sentinel lymph node biopsy combined with wire localized lymph node biopsy (SLNB+WLNB) to identify breast cancer patients with 1-2 sonographically abnormal axillary lymph nodes who may safely avoid axillary lymph node dissection (ALND). A total of 84 patients with clinically node-negative, cT1-2 invasive breast cancer and biopsy-proven axillary lymph node metastasis will be enrolled. The primary endpoint is the proportion of patients with total positive lymph nodes ≤2 after SLNB+WLNB.
Axillary surgery in breast cancer has evolved toward individualized and less invasive approaches. However, the optimal axillary management remains controversial for patients with clinically node-negative disease but abnormal axillary lymph nodes detected by ultrasound and confirmed metastatic by biopsy. This prospective cohort study will evaluate whether SLNB combined with WLNB can accurately assess axillary tumor burden and identify patients suitable for omission of ALND. Patients will undergo SLNB and wire localized biopsy of abnormal lymph nodes according to routine clinical practice. Pathological findings will be collected and analyzed. The study will assess the proportion of patients with ≤2 positive lymph nodes, diagnostic concordance between SLNB and WLNB, and factors associated with axillary tumor burden.
Study Type
OBSERVATIONAL
Enrollment
84
Peking University Cancer Hospital
Beijing, China
Proportion of Patients with Total Positive Lymph Nodes ≤2
To determine the proportion and 95% confidence interval of patients whose total number of positive lymph nodes after SLNB combined with WLNB is ≤2.
Time frame: Perioperative
Comparison of Low Axillary Tumor Burden Between Patients with 1 vs 2 Abnormal Lymph Nodes on Ultrasound
Time frame: Perioperative
Positive Rate of Wire Localized Lymph Nodes Alone
Time frame: Perioperative
Concordance Between Sentinel Lymph Node and Wire Localized Lymph Node Metastasis
Time frame: Perioperative
Additional Positive Lymph Nodes After Axillary Lymph Node Dissection
Time frame: Perioperative
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