SLNB Combined With WLNB for Axillary De-escalation in Breast Cancer Patients With Abnormal Axillary Nodes

Prospective Evaluation of Sentinel Lymph Node Biopsy Combined With Wire Localized Lymph Node Biopsy for Omitting Axillary Lymph Node Dissection in Breast Cancer Patients With 1-2 Sonographically Abnormal Lymph Nodes: A Diagnostic Study

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.

Inclusion Criteria:

1. Female patients pathologically confirmed with primary invasive breast cancer via core needle biopsy;
2. Aged 18 years or older;
3. 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;
4. Maximum diameter of breast tumor ≤5 cm (cT1-2);
5. No distant metastasis detected on tumor staging examinations;
6. No prior neoadjuvant therapy received;
7. Sentinel lymph node biopsy combined with wire-localized lymph node biopsy completed by attending physicians per routine clinical practice;
8. Patients meet one of the following criteria for combined lymph node biopsy results and surgical management: total number of positive lymph nodes is 1-2 with breast-conserving surgery and omission of axillary lymph node dissection; or total number of positive lymph nodes is 1-2 with modified radical mastectomy; or total number of positive lymph nodes exceeds 2, with axillary lymph node dissection performed regardless of breast-conserving surgery or total mastectomy;
9. Voluntarily participating in this observational study and signing an informed consent form.

Exclusion Criteria:

1. Bilateral breast cancer;
2. Stage IV breast cancer;
3. Receipt of neoadjuvant therapy prior to surgery;
4. Previous ipsilateral axillary surgery history (e.g., osmidrosis surgery, lymph node biopsy) and history of axillary radiotherapy;
5. Coexistence of other malignant tumors within the past 5 years, excluding cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.;
6. Pregnant or lactating women;
7. Severe cardiac and pulmonary insufficiency precluding surgical tolerance.