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Clinical Trials in China / NCT07791771
Starting soon Observational

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

NCT07791771 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Cancer Hospital & Institute
Phase
Observational
Started
2026-07-31
Last updated
2026-08-28

Condition(s) studied

Breast Cancer

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijing China

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07791771 on ClinicalTrials.gov ↗ ← All trials in China