Study of Metastatic Breast Cancer (ER+/HER2-) using NCRAS data
Research type
Research Study
Full title
Patient characteristics, treatment patterns, resource utilisation, and outcomes of patients with ER positive/HER2 negative metastatic breast cancer in England – A Cohort Study using the National Cancer Registration and Analysis Service datasets
IRAS ID
301253
Contact name
Kazue Kikuchi
Contact email
Sponsor organisation
Centara
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
Breast cancer (BC) is the most common type of cancers among females in the UK in 2017 with an incidence rate of 166.7 per 100,000 and, whilst it is rare among males, with an incidence of 1.3 per 1000,000, the latter have poorer outcomes. Recent introduction of a family of drugs known as cycline dependent kinase inhibitors (CDK4/6) has shown to be effective and tolerable in ER+ HER2- metastatic BC patients. Given their recent introduction, there is a lack of published real world data on the types (including CDK4/6 inhibitors) and sequences of treatment in the management of metastatic breast cancer in England, and especially on male patients. This retrospective observational study using National Cancer Registration and Analysis Service (NCRAS) aims to describe the demographic clinical characteristic and treatment patterns of patients with metastatic breast cancer (type ER +/HER2 -) in routine clinical practice and their outcomes in term of survival rates according to the specific treatment strategies. The study population will include de novo metastatic BC at diagnosis or have progressed to this advance stage from an earlier stage between 2013 and 2019 (or later depending on data availability). The patients will be followed up until the most recent point in time. Findings from this study will help with understanding current treatment strategies and the survival rates of metastatic BC in England, especially among males too, thus providing clinicians, researchers and patients with information about current treatments and on how to optimise therapeutic strategies and improve care and patients’ outcomes.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
21/WM/0204
Date of REC Opinion
16 Aug 2021
REC opinion
Further Information Favourable Opinion