Targeted sentinel node biopsy for breast cancer patients with limited axillary nodal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* cT1-2N1M0 breast cancer\*
* FNA or core biopsy confirmed axillary nodal metastases
* ≤2 abnormal nodes on imaging
* The biopsied involved node should be marked using any technique
* Undergo a dual tracer or single tracer sentinel node biopsy with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)‡
* If the sentinel node(s) cannot be localised, axillary node sampling may be performed \*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.

cN1 includes nodes detected by imaging studies or clinical examination.

‡If the marked node cannot be localised, patient will remain in NodeSMART. The decision regarding any further axillary treatment will be made by the treating MDT and recorded in the audit.

Exclusion Criteria:

* Neoadjuvant chemotherapy†
* Previous ipsilateral axillary lymph node dissection
* cT3-4 breast cancer
* ≥3 abnormal nodes on imaging

  * Neoadjuvant endocrine therapy is permitted.

Where it's running

• 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
• University Hospitals of Leicester NHS Trust
  Leicester, United Kingdom Recruiting

Study contacts

• Study coordinator: Amit Goyal
• Email: amit.goyal@nhs.net
• Phone: 01332 786958

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.