Clinical trials / NCT07085442
Recruiting

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

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…

ClinicalTrials.gov IDNCT07085442
PhaseNot Applicable
Enrollment400
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust
Age18 Years
SexALL
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Conditions studied

Breast Cancer, Axillary Lymph Nodes Dissection, Axillary Metastases, Sentinel Lymph Node Biopsy (SLNB), Node Positive Breast Cancer, Axilla; Breast, Axillary Ultrasound

About this study

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. The AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND. Targeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial \[ClinicalTrials.govNCT04109079\]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se. Current ASCO…

Interventions

Primary outcomes

Eligibility information

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 T 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

Study locations

Showing 10 of 12 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.