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

NCT07791771 | Not Yet Recruiting

• 1 other identifier: BC-P42
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast cancer; Axillary lymph node; Sentinel lymph node biopsy; Wire localized lymph node biopsy; Axillary de-escalation

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperative

Secondary Outcomes (4)

• Comparison of Low Axillary Tumor Burden Between Patients with 1 vs 2 Abnormal Lymph Nodes on Ultrasound

  Perioperative

• Positive Rate of Wire Localized Lymph Nodes Alone

  Perioperative

• Concordance Between Sentinel Lymph Node and Wire Localized Lymph Node Metastasis

  Perioperative

• Additional Positive Lymph Nodes After Axillary Lymph Node Dissection

  Perioperative

Study Arms (1)

SLNB + WLNB Cohort

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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);
• No distant metastasis detected on tumor staging examinations;
• No prior neoadjuvant therapy received;
• Sentinel lymph node biopsy combined with wire-localized lymph node biopsy completed by attending physicians per routine clinical practice;
• 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;
• Voluntarily participating in this observational study and signing an informed consent form.

You may not qualify if:

• 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;
• 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.;
• Pregnant or lactating women;
• Severe cardiac and pulmonary insufficiency precluding surgical tolerance.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, 100142, China

Location

Related Publications (3)

• Matar-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 RESULT

• Man 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 RESULT

• Boyle 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jiwei Wang, MD

  Breast Center, Peking University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiwei Wang, MD

CONTACT

0086-10-88197829; jiweiwang@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 28, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)