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.
Female patients pathologically confirmed with primary invasive breast cancer via core needle biopsy;
Aged 18 years or older;
No enlarged lymph nodes palpable in the axilla on clinical examination; ultrasound reveals 1 or 2 abnormal ipsilateral axillary lymph nodes with malignant features (cortical thickening >3 mm, hypoechoic, etc.), and at least one of them is confirmed metastatic by biopsy;
Maximum diameter of breast tumor ≤5 cm (cT1-2);
Bilateral breast cancer;
Stage IV breast cancer;
Receipt of neoadjuvant therapy prior to surgery;
Previous ipsilateral axillary surgery history (e.g., osmidrosis surgery, lymph node biopsy) and history of axillary radiotherapy;
This prospective observational cohort study will enroll female patients with invasive breast cancer who have clinically node-negative axilla on physical examination, but 1-2 abnormal axillary lymph nodes detected by ultrasound and confirmed metastatic by biopsy. Eligible patients will have cT1-2 breast cancer without distant metastasis and will undergo sentinel lymph node biopsy combined with wire localized lymph node biopsy. A total of 84 patients will be included.
Cohort
Prospective
Not listed
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.
Comparison of Low Axillary Tumor Burden Between Patients with 1 vs 2 Abnormal Lymph Nodes on Ultrasound
Positive Rate of Wire Localized Lymph Nodes Alone
Concordance Between Sentinel Lymph Node and Wire Localized Lymph Node Metastasis
Additional Positive Lymph Nodes After Axillary Lymph Node Dissection
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