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  

Gareth Irwin, Fiona Bannon, Charlotte Coles, Ellen Copson, Ramsey Cutress, Rajiv Dave, Margaret Grayson, Chris Holcombe, Shelley Potter, Stuart McIntosh

Research output: Contribution to journalArticle (Academic Journal)

2 Citations (Scopus)
8 Downloads (Pure)

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 - 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.
Original languageEnglish
JournalInternational Journal of Surgery Protocols
Early online date11 Nov 2019
DOIs
Publication statusE-pub ahead of print - 11 Nov 2019

Keywords

  • breast cancer
  • neoadjuvant chemotherapy
  • neoadjuvant endocrine therapy
  • surgery
  • pathology
  • radiology
  • patterns of care
  • outcomes

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