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Study identifier: NCT07085442 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Breast Cancer · Axillary Lymph Nodes Dissection · Axillary Metastases  ·  Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

PhaseN/A
Planned participants300
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

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…

This description comes directly from the study's public registry record.

Talk to the study team

Amit Goyal  ·  01332 786958  ·  amit.goyal@nhs.net

Always discuss trial participation with your own doctor first.

Locations (12)

Burnley General Teaching HospitalBurnley, United KingdomRecruiting
Addenbrooke's HospitalCambridge, United KingdomRecruiting
University Hospitals of Derby and BurtonDerby, United KingdomRecruiting
Gartnavel General HospitalGlasgow, United KingdomRecruiting
Wycombe HospitalHigh Wycombe, United KingdomRecruiting
Liverpool University Hospitals NHS Foundation TrustLiverpool, United KingdomRecruiting
Royal Alexandra HospitalPaisley, United KingdomRecruiting
The Shrewsbury and Telford Hospital NHS TrustShrewsbury, United KingdomRecruiting
Mersey and West Lancashire Teaching HospitalsSt Helens, United KingdomRecruiting
University Hospital of North Tees and HartlepoolStockton-on-Tees, United KingdomRecruiting
Warrington and Halton Teaching HospitalsWarrington, United KingdomRecruiting
The Royal Wolverhampton NHS TrustWolverhampton, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT07085442