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
Sponsor study identifier
observational
84
1 country
1
Study Start
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 9, 2026
Actual (reported)August 28, 2026
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
Peking University Cancer Hospital
Beijing, 100142, China
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.
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.
Jiwei Wang, MD
Breast Center, Peking University Cancer Hospital
First Submitted
August 9, 2026
First Posted
August 28, 2026
Study Start
July 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedContact the study team to confirm eligibility.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 28, 2026
Record last verified: 2026-08
Individual participant data will not be shared because the study is a single-center exploratory observational study. Data will be protected according to institutional policies and applicable regulations.
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Source: ClinicalTrials.gov.
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