Evidence map›Paper›PMID 40204306›Full record

ArticleBMJ open2025

SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer-protocol for a phase III randomised multicentre trial.

Kenneth Elder, Charlotte Coles, David Dodwell, Beatrix Elsberger, Jessica Foster, Claire Gaunt, Julia R Henderson, Iain Lyburn, Claire Mabena, Jenna Morgan and 16 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Kenneth ElderBreast Unit, Western General Hospital, Edinburgh, UK.
Charlotte ColesDepartment of Oncology, University of Cambridge, Cambridge, UK.
David DodwellPopulation Health, University of Oxford, Oxford, UK.
Beatrix ElsbergerAberdeen Royal Infirmary, Aberdeen, UK.
Jessica FosterCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Claire GauntCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Julia R HendersonLinda McCartney Centre, Royal Liverpool University Hospital, Liverpool, UK.
Iain LyburnGloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.
Claire MabenaCentral and East London Breast Screening Services, Royal Free London NHS Foundation Trust, London, England, UK.
Jenna MorganDivision of Clinical Medicine, The University of Sheffield Medical School, Sheffield, UK.
Zohal NabiNational Radiotherapy Trials QA Group, Mount Vernon Cancer Centre, Northwood, England, UK.
Sangeetha ParamasivanPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UK.
Sarah PinderSchool of Cancer and Pharmaceutical Sciences, King's College London, London, England, UK.
Sarah PirrieCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Shelley PotterTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UK.ORCID http://orcid.org/0000-0002-6977-312X
Tracy RobertsInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, England, UK.
Nisha SharmaBreast Unit, St James's Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.
Elizabeth SouthgateCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Hilary StobartIndependent Cancer Patients' Voice, London, UK.
Amruta TalwalkarWrightington Wigan and Leigh NHS Foundation Trust, Wigan, UK.
Sian Taylor-PhillipsWarwick Medical School, University of Warwick, Coventry, England, UK.ORCID http://orcid.org/0000-0002-1841-4346
William TehCentral and East London Breast Screening Service, Royal Free London NHS Foundation Trust, London, England, UK.
Elliot TurnerCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Matthew G WallisCambridge Breast Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK.
Dan ReaCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Stuart McIntoshPatrick G Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, Northern Ireland, UK s.mcintosh@qub.ac.uk.ORCID http://orcid.org/0000-0002-4123-9611

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as 'overdiagnosed' cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL (

methodsSMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer. TRIAL REGISTRATION NUMBER: ISRCTN12240119.

Indexed as

Breast NeoplasmsMinimally Invasive Surgical ProceduresClinical Trials, Phase III as TopicEarly Detection of CancerEquivalence Trials as TopicFemaleHumansMammographyMulticenter Studies as TopicNeoplasm Recurrence, LocalProspective StudiesRandomized Controlled Trials as TopicVacuumBreast imagingBreast surgeryBreast tumoursClinical Trial

Identifiers

PMID40204306
PMCPMC11979497

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.