Targeted sentinel node biopsy for breast cancer patients with limited axillary nodal disease
NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
University Hospitals of Derby and Burton NHS Foundation Trust · NCT07085442
This audit will test if removing the marked node along with the sentinel nodes can identify people with only 1–2 positive axillary nodes so some can avoid a full axillary dissection, for adults with cT1-2 breast cancer and biopsy-proven axillary metastases with no more than two abnormal nodes on imaging.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals of Derby and Burton NHS Foundation Trust (other) |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Burnley and 11 other locations) |
| Trial ID | NCT07085442 on ClinicalTrials.gov |
What this trial studies
This observational audit follows patients with cT1-2N1M0 breast cancer who have biopsy-proven axillary metastases and up to two abnormal nodes on imaging. Sites mark the most abnormal node at biopsy (using clips, dye, magnetic seeds or reflectors) and perform targeted sentinel node biopsy (TSNB) at primary surgery using single or dual tracers, aiming to remove at least three nodes including the marked node. Patients with 1–2 macrometastases among the removed nodes are the focus, and if the sentinel node cannot be localized axillary node sampling is used to achieve the same assessment. The protocol aligns with ATNEC guidance and is intended to better define nodal tumour burden to inform whether axillary radiotherapy rather than full dissection is appropriate.
Who should consider this trial
Good fit: Ideal candidates are adults with cT1-2N1M0 breast cancer, FNA or core biopsy–confirmed axillary metastases, no prior ipsilateral axillary surgery, no neoadjuvant chemotherapy, and imaging showing one or two abnormal axillary nodes.
Not a fit: Patients with three or more abnormal nodes on imaging, cT3-4 tumours, prior ipsilateral axillary surgery, or those receiving neoadjuvant chemotherapy are unlikely to benefit from this targeted sentinel node approach.
Why it matters
Potential benefit: If successful, this approach could let some patients avoid a full axillary lymph node dissection and its associated complications by identifying those with low nodal burden.
How similar studies have performed: Randomized trials such as AMAROS and OTOASOR showed axillary radiotherapy provided similar regional control to axillary dissection for patients with up to two positive sentinel nodes, and targeted axillary techniques have been increasingly used though prospective evidence specific to TSNB in this exact population remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: * Neoadjuvant chemotherapy * Previous ipsilateral axillary nodal surgery * cT3-4 breast cancer * ≥3 abnormal nodes on imaging
Where this trial is running
Burnley and 11 other locations
- Burnley General Teaching Hospital — Burnley, United Kingdom (RECRUITING)
- Addenbrooke's Hospital — Cambridge, United Kingdom (RECRUITING)
- University Hospitals of Derby and Burton — Derby, United Kingdom (RECRUITING)
- Gartnavel General Hospital — Glasgow, United Kingdom (RECRUITING)
- Wycombe Hospital — High Wycombe, United Kingdom (RECRUITING)
- Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom (RECRUITING)
- Royal Alexandra Hospital — Paisley, United Kingdom (RECRUITING)
- The Shrewsbury and Telford Hospital NHS Trust — Shrewsbury, United Kingdom (RECRUITING)
- Mersey and West Lancashire Teaching Hospitals — St Helens, United Kingdom (RECRUITING)
- University Hospital of North Tees and Hartlepool — Stockton-on-Tees, United Kingdom (RECRUITING)
- Warrington and Halton Teaching Hospitals — Warrington, United Kingdom (RECRUITING)
- The Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Amit Goyal
- Email: amit.goyal@nhs.net
- Phone: 01332 786958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Axillary Lymph Nodes Dissection, Axillary Metastases, Sentinel Lymph Node Biopsy, Node Positive Breast Cancer, Axilla, Breast, Axillary Ultrasound