SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trial
Introduction Mammographic 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, a...
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BMJ Publishing Group
2025-04-01
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| Online Access: | https://bmjopen.bmj.com/content/15/4/e099702.full |
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| author | Sian Taylor-Phillips Tracy Roberts Nisha Sharma Sangeetha Paramasivan Shelley Potter Stuart McIntosh David Dodwell Julia R Henderson Hilary Stobart Sarah Pinder Jenna Morgan Matthew G Wallis Charlotte Coles Zohal Nabi Beatrix Elsberger William Teh Kenneth Elder Jessica Foster Claire Gaunt Iain Lyburn Claire Mabena Sarah Pirrie Elizabeth Southgate Amruta Talwalkar Elliot Turner Dan Rea |
| author_facet | Sian Taylor-Phillips Tracy Roberts Nisha Sharma Sangeetha Paramasivan Shelley Potter Stuart McIntosh David Dodwell Julia R Henderson Hilary Stobart Sarah Pinder Jenna Morgan Matthew G Wallis Charlotte Coles Zohal Nabi Beatrix Elsberger William Teh Kenneth Elder Jessica Foster Claire Gaunt Iain Lyburn Claire Mabena Sarah Pirrie Elizabeth Southgate Amruta Talwalkar Elliot Turner Dan Rea |
| author_sort | Sian Taylor-Phillips |
| collection | DOAJ |
| description | Introduction Mammographic 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 (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.Methods SMALL 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. |
| format | Article |
| id | doaj-art-4f0bd9078dda4279a6ed227e81faa1a4 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-4f0bd9078dda4279a6ed227e81faa1a42025-08-20T03:05:25ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2025-099702SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trialSian Taylor-Phillips0Tracy Roberts1Nisha Sharma2Sangeetha Paramasivan3Shelley Potter4Stuart McIntosh5David Dodwell6Julia R Henderson7Hilary Stobart8Sarah Pinder9Jenna Morgan10Matthew G Wallis11Charlotte Coles12Zohal Nabi13Beatrix Elsberger14William Teh15Kenneth Elder16Jessica Foster17Claire Gaunt18Iain Lyburn19Claire Mabena20Sarah Pirrie21Elizabeth Southgate22Amruta Talwalkar23Elliot Turner24Dan Rea25Warwick Medical School, University of Warwick, Coventry, England, UKInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, England, UKBreast Unit, St James’s Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UKPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKPatrick G Johnston Centre for Cancer Research, Queen’s University Belfast, Belfast, Northern Ireland, UKPopulation Health, University of Oxford, Oxford, UKLinda McCartney Centre, Royal Liverpool University Hospital, Liverpool, UKIndependent Cancer Patients’ Voice, London, UKSchool of Cancer and Pharmaceutical Sciences, King’s College London, London, England, UKDivision of Clinical Medicine, The University of Sheffield Medical School, Sheffield, UKCambridge Breast Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UKDepartment of Oncology, University of Cambridge, Cambridge, UKNational Radiotherapy Trials QA Group, Mount Vernon Cancer Centre, Northwood, England, UKAberdeen Royal Infirmary, Aberdeen, UKCentral and East London Breast Screening Service, Royal Free London NHS Foundation Trust, London, England, UKBreast Unit, Western General Hospital, Edinburgh, UKCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UKCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UKGloucestershire Hospitals NHS Foundation Trust, Cheltenham, UKCentral and East London Breast Screening Services, Royal Free London NHS Foundation Trust, London, England, UKCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UKCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UKWrightington Wigan and Leigh NHS Foundation Trust, Wigan, UKCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UKCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UKIntroduction Mammographic 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 (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.Methods SMALL 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.https://bmjopen.bmj.com/content/15/4/e099702.full |
| spellingShingle | Sian Taylor-Phillips Tracy Roberts Nisha Sharma Sangeetha Paramasivan Shelley Potter Stuart McIntosh David Dodwell Julia R Henderson Hilary Stobart Sarah Pinder Jenna Morgan Matthew G Wallis Charlotte Coles Zohal Nabi Beatrix Elsberger William Teh Kenneth Elder Jessica Foster Claire Gaunt Iain Lyburn Claire Mabena Sarah Pirrie Elizabeth Southgate Amruta Talwalkar Elliot Turner Dan Rea SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trial BMJ Open |
| title | SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trial |
| title_full | SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trial |
| title_fullStr | SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trial |
| title_full_unstemmed | SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trial |
| title_short | SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—protocol for a phase III randomised multicentre trial |
| title_sort | small open surgery versus minimally invasive vacuum assisted excision for small screen detected breast cancer protocol for a phase iii randomised multicentre trial |
| url | https://bmjopen.bmj.com/content/15/4/e099702.full |
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