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New surgical audit aims to reduce arm swelling in breast cancer patients

NCT ID NCT07085442

Knowledge-focused Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 7 times

Summary

This study is auditing a surgical technique called Targeted Sentinel Node Biopsy (TSNB) for breast cancer patients who have a small number of cancer cells in their lymph nodes. The goal is to see if this less invasive procedure can accurately identify cancer spread while causing less arm swelling than traditional lymph node removal. Researchers will track outcomes in 300 patients across the UK.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Targeted Sentinel Node Biopsy (TSNB) - a surgical procedure
What this could lead to
If successful, this could show that TSNB is a safe and effective way to stage breast cancer, potentially reducing the need for more extensive lymph node removal and lowering the risk of arm swelling.
What could go wrong
This is an observational audit, not a treatment trial, so it won't directly test a new therapy. Results may not change practice immediately, and the procedure's accuracy depends on surgeon skill and patient selection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

cT1-2N1M0 breast cancer patients aged 18 years or older, with needle biopsy proven nodal metastases, ≤2 abnormal nodes on imaging, and are undergoing sentinel node biopsy and removal of the marked involved node.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm metastatic malignant neoplasm in the lymph nodes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axilla; breast Axillary lymph nodes dissection Axillary metastases Axillary ultrasound Breast cancer Node positive breast cancer Sentinel lymph node biopsy (SLNB)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, United Kingdom

  • Burnley General Teaching Hospital

    RECRUITING

    Burnley, United Kingdom

  • Gartnavel General Hospital

    RECRUITING

    Glasgow, United Kingdom

  • Liverpool University Hospitals NHS Foundation Trust

    RECRUITING

    Liverpool, United Kingdom

  • Mersey and West Lancashire Teaching Hospitals

    RECRUITING

    St Helens, United Kingdom

  • Royal Alexandra Hospital

    RECRUITING

    Paisley, United Kingdom

  • The Royal Wolverhampton NHS Trust

    RECRUITING

    Wolverhampton, WV10 0QP, United Kingdom

  • The Shrewsbury and Telford Hospital NHS Trust

    RECRUITING

    Shrewsbury, United Kingdom

  • University Hospital of North Tees and Hartlepool

    RECRUITING

    Stockton-on-Tees, United Kingdom

  • University Hospitals of Derby and Burton

    RECRUITING

    Derby, United Kingdom

  • Warrington and Halton Teaching Hospitals

    RECRUITING

    Warrington, United Kingdom

  • Wycombe Hospital

    RECRUITING

    High Wycombe, HP11 2TT, United Kingdom

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