Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- SLNB + WLNB Cohort
- description
- Patients with clinically node-negative breast cancer, 1-2 abnormal axillary lymph nodes detected by ultrasound, and biopsy-confirmed axillary lymph node metastasis will undergo sentinel lymph node biopsy combined with wire localized lymph node biopsy. Clinical and pathological data will be collected prospectively.
Primary outcomes (1)
- measure
- Proportion of Patients with Total Positive Lymph Nodes ≤2
- timeFrame
- Perioperative
- description
- To determine the proportion and 95% confidence interval of patients whose total number of positive lymph nodes after SLNB combined with WLNB is ≤2.
Secondary outcomes (4)
- measure
- Comparison of Low Axillary Tumor Burden Between Patients with 1 vs 2 Abnormal Lymph Nodes on Ultrasound
- timeFrame
- Perioperative
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTMatar-Ujvary R, Sevilimedu V, Morrow M. Are Clinically Node-Negative Patients with a Positive Preoperative Axillary Lymph Node Biopsy Appropriate Candidates for Sentinel Lymph Node Biopsy? Ann Surg Oncol. 2025 Jan;32(1):92-97. doi: 10.1245/s10434-024-16321-6. Epub 2024 Oct 12. PMID 39394489
- RESULTMan V, Luk WP, Fung LH, Kwong A. The role of pre-operative axillary ultrasound in assessment of axillary tumor burden in breast cancer patients: a systematic review and meta-analysis. Breast Cancer Res Treat. 2022 Nov;196(2):245-254. doi: 10.1007/s10549-022-06699-w. Epub 2022 Sep 22. PMID 36138294
- RESULTBoyle MK, Amersi F, Chung A, Tseng J, Giuliano AE. Comparison of Targeted Axillary Dissection with Sentinel Node Biopsy Alone on Nodal Recurrence for Patients who have Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy. Ann Surg Oncol. 2025 Jul;32(7):4847-4854. doi: 10.1245/s10434-025-17197-w. Epub 2025 Mar 25. PMID 40131624