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Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery

Recruitingn/aAges 18 Years - anyAllUniversity Hospitals of Derby and Burton NHS Foun…
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In plain words

What the trial is, and whether it could suit you

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 needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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‡. * patients with T3 tumours on post-operative histology will remain eligible. For multifocal/multicentric tumours, the cT stage is based on the size of the largest invasive tumour focus rather than the combined size of all tumours. * If \<3 lymph nodes are identified on histology, patient will remain in the NodeSMART registry. The decision regarding any further axillary treatment will be made by the treating MDT and recorded in the registry. Exclusion Criteria: * Neoadjuvant chemotherapy† * Previous ipsilateral axillary lymph node dissection * cT3-4 breast cancer * ≥3 abnormal nodes on imaging * Neoadjuvant endocrine therapy is permitted.
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What it tests

  • Targeted Sentinel Node Biopsy (TSNB)
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Where

14 sites
Burnley General Teaching Hospital
Burnley, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
University Hospitals of Derby and Burton
Derby, United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom
Wycombe Hospital
High Wycombe, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
Royal Alexandra Hospital
Paisley, United Kingdom

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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