Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
NCT ID: NCT07085442
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-01-17
2032-12-31
Brief Summary
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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 guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a clinically appropriate alternative in this patient population.
The UK-ANZ POSNOC trial randomised 1,900 patients with \<3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with \<3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.
Notably, patients with biopsy-confirmed metastases and \<3 macrometastases on SNB/TAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.
NodeSMART is a prospective audit collecting data on all patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term "Targeted Axillary Dissection" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).
Detailed Description
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Timing The node may be marked at the time of needle biopsy or at a separate visit.
Single vs multiple node marking It is not necessary to mark more than one node, even if multiple nodes are biopsied or appear malignant. The most abnormal-appearing node should be marked.
Black dye node marking Inject 0.2-0.4 ml of black dye into the cortex of the node Do not inject around the node or into the needle tract
If the marked node is not found or if multiple black nodes are identified the surgeon may stop once a total of four nodes have been removed
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with biopsy proven nodal metastases (cN1) and not receiving neoadjuvant chemotherapy
Patients with T1 or T2 tumours with biopsy proven nodal metastases (cN1) and with ≤2 abnormal nodes on axillary ultrasound
Targeted Sentinel Node Biopsy (TSNB)
Targeted Sentinel Node Biopsy will be performed according to routine local practice. The procedure has been standardised for the post-NACT setting as part of the ongoing ATNEC trial. Sites are advised to follow the ATNEC protocol in the primary surgery setting, using either a dual- or single-tracer sentinel node biopsy technique, with localisation and removal of the marked biopsy proven positive node, and removal of at least 3 nodes.
Interventions
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Targeted Sentinel Node Biopsy (TSNB)
Targeted Sentinel Node Biopsy will be performed according to routine local practice. The procedure has been standardised for the post-NACT setting as part of the ongoing ATNEC trial. Sites are advised to follow the ATNEC protocol in the primary surgery setting, using either a dual- or single-tracer sentinel node biopsy technique, with localisation and removal of the marked biopsy proven positive node, and removal of at least 3 nodes.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Previous ipsilateral axillary nodal surgery
* cT3-4 breast cancer
* ≥3 abnormal nodes on imaging
18 Years
ALL
No
Sponsors
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University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
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Dr Amit Goyal
Chief Investigator
Principal Investigators
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Amit Goyal
Role: STUDY_CHAIR
University Hospitals of Derby and Burton NHS Foundation Trust
Locations
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Burnley General Teaching Hospital
Burnley, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Gartnavel General Hospital
Glasgow, , United Kingdom
Wycombe Hospital
High Wycombe, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, , United Kingdom
Royal Alexandra Hospital
Paisley, , United Kingdom
Mersey and West Lancashire Teaching Hospitals
St Helens, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Inder Kumar
Role: primary
Eleftheria Kleidi
Role: primary
Emanuele Garreffa
Role: primary
Laszlo Romics
Role: primary
Fiona Tsang-Wright
Role: primary
Julia Henderson
Role: primary
Laura Arthur
Role: primary
Leena Chagla
Role: primary
Other Identifiers
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PID 46
Identifier Type: -
Identifier Source: org_study_id