Status:
RECRUITING
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Lead Sponsor:
University Hospitals of Derby and Burton NHS Foundation Trust
Conditions:
Breast Cancer
Axillary Lymph Nodes Dissection
Eligibility:
All Genders
18+ years
Brief Summary
Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needl...
Detailed Description
Guidelines for node marking: Sites are advised to follow the same standards used in the ongoing ATNEC breast cancer trial. At least three nodes should be removed to allow adequate assessment of nodal...
Eligibility Criteria
Inclusion
- cT1-2N1M0 breast cancer
- FNA or core biopsy confirmed axillary nodal metastases
- ≤2 abnormal nodes on imaging
- Undergo a dual tracer or single tracer sentinel node biopsy along with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)
- 1 or 2 macrometastases identified in the removed nodes, with at least three nodes removed
- If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.
- If the node is not marked or the marked node is not removed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.
Exclusion
- Neoadjuvant chemotherapy
- Previous ipsilateral axillary nodal surgery
- cT3-4 breast cancer
- ≥3 abnormal nodes on imaging
Key Trial Info
Start Date :
January 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07085442
Start Date
January 17 2025
End Date
December 1 2032
Last Update
February 10 2026
Active Locations (10)
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1
Burnley General Teaching Hospital
Burnley, United Kingdom
2
Addenbrooke's Hospital
Cambridge, United Kingdom
3
University Hospitals of Derby and Burton
Derby, United Kingdom
4
Gartnavel General Hospital
Glasgow, United Kingdom