The NeST (neoadjuvant systemic therapy in breast cancer) study - Protocol for a prospective multi-centre cohort study to assess the current utilization and short-term outcomes of neoadjuvant systemic therapies in breast cancer

G W Irwin; F Bannon; C E Coles; E Copson; R I Cutress; R V Dave; M Grayson; C Holcombe; S Irshad; C O'Brien; R L O'Connell; C Palmieri; A M Shaaban; N Sharma; J Singh; I Whitehead; S Potter; S A McIntosh

doi:10.1016/j.isjp.2019.10.002

The NeST (neoadjuvant systemic therapy in breast cancer) study - Protocol for a prospective multi-centre cohort study to assess the current utilization and short-term outcomes of neoadjuvant systemic therapies in breast cancer

Int J Surg Protoc. 2019 Nov 11:18:5-11. doi: 10.1016/j.isjp.2019.10.002. eCollection 2019.

Authors

G W Irwin¹, F Bannon², C E Coles³, E Copson⁴, R I Cutress⁴, R V Dave⁵, M Grayson⁶, C Holcombe⁷, S Irshad^{8

9}, C O'Brien¹⁰, R L O'Connell¹¹, C Palmieri¹², A M Shaaban¹³, N Sharma¹⁴, J Singh¹⁵, I Whitehead¹⁶, S Potter^{17

18}, S A McIntosh¹⁹

Affiliations

¹ Belfast City Hospital, Belfast Health and Social Care Trust, 51 Lisburn Road, Belfast BT98 7AB, UK.
² Centre for Public Health, Queen's University, Belfast, UK.
³ Oncology Centre, Box 193, University of Cambridge, Hills Road, Cambridge CB2 0QQ, UK.
⁴ Cancer Sciences Academic Unit, University of Southampton, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK.
⁵ Nightingale Breast Centre, Manchester University Foundation Trust, Southmoor Road, Wythenshawe, Manchester M23 9LT, UK.
⁶ Northern Ireland Cancer Research Consumer Forum, Belfast, Northern Ireland, UK.
⁷ North West Cancer Research Centre, University of Liverpool, 200 London Road, Liverpool L3 9TA, UK.
⁸ Research Oncology, Kings College London, SE1 9RT, UK.
⁹ Guys & St Thomas' NHS Trust, London SE1 9RT, UK.
¹⁰ The Christie NHS Foundation Trust, Wilmslow Road, Manchester M20 2BX, UK.
¹¹ Department of Breast Surgery, Royal Marsden NHS Foundation Trust. Downs Road, Sutton, Surrey SM2 5PT, UK.
¹² Institute of Translational Medicine, University of Liverpool, Liverpool L69 3BX, UK.
¹³ Queen Elizabeth Hospital Birmingham and University of Birmingham, Birmingham B15 2GW, UK.
¹⁴ Breast Unit, Level 1 Chancellor Wing, St James Hospital, Beckett Street, Leeds LS97TF, UK.
¹⁵ University Hospitals Birmingham, Edgbaston, Birmingham B15 2GW, UK.
¹⁶ Burney Breast Unit, St Helens & Knowsley Teaching Hospitals NHS Trust, Marshalls Cross Road, St Helens WA9 3DA, UK.
¹⁷ Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK.
¹⁸ Bristol Breast Care Centre, North Bristol NHS Trust, Southmead Road, Bristol BS10 5NB, UK.
¹⁹ Centre for Cancer Research and Cell Biology, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7AE, UK.

Abstract

Introduction: Neoadjuvant systemic therapy (NST) has several potential advantages in the treatment of breast cancer. However, there is currently considerable variation in NST use across the UK. The NeST study is a national, prospective, multicentre cohort study that will investigate current patterns of care with respect to NST in the UK.

Methods and analysis: Phase 1 - a national practice questionnaire (NPQ) to survey current practice.Phase 2 - a multi-centre prospective cohort study of breast cancer patients, undergoing NST.Women undergoing NST as their MDT recommended primary breast cancer treatment between December 2017 and May 2018 will be included. The breast surgery and oncological professional associations and the trainee research collaborative networks will encourage participation by all breast cancer centres.Patient demographics, radiological, oncological, surgical and pathological data will be collected, including complications and the need for further intervention/treatment. Data will be collated to establish current practice in the UK, regarding NST usage and variability of access and provision of these therapies. Prospective data on 600 patients from ~50 centres are anticipated.Trial registration: ISRCTN11160072.

Ethics and dissemination: Research ethics approval is not required for this study, as per the online Health Research Authority decision tool. The information obtained will provide valuable insights to help patients make informed decisions about their treatment. These data should establish current practice in the UK concerning NST, inform future service delivery as well as identifying further research questions.This protocol will be disseminated through the Mammary Fold Academic Research Collaborative (MFAC), the Reconstructive Surgery Trials Network and the Association of Breast Surgery. Participating units will have access to their own data and collective results will be presented at relevant conferences and published in appropriate peer-reviewed journals, as well as being made accessible to relevant patient groups.

Keywords: Breast cancer; Neoadjuvant chemotherapy; Neoadjuvant endocrine therapy; Outcomes; Pathology; Patterns of care; Radiology; Surgery.

Abstract

Grants and funding