Management of HR+/HER2- breast cancer in England
Research type
Research Study
Full title
Epidemiology and treatment of HR+/HER2- breast cancer in England
IRAS ID
325807
Contact name
Jennifer Davidson
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd.
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Breast cancer (BC) is the most diagnosed cancer and frequent cause of cancer-related deaths among women worldwide. In 2020, 80.3% of new BC cases in England were diagnosed between stages I-III (early BC; eBC), and between 5-10% of individuals have metastatic BC (mBC) at the time of diagnosis. mBC develops in almost 12% of individuals with non-metastatic BC at the time of diagnosis. Endocrine therapy is the preferred treatment for HR+/HER2- BC, and the addition of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) to endocrine therapy has been shown to improve outcomes for HR+ BC patients, becoming the standard of care for treatment of HR+/HER2- mBC.
This is a retrospective cohort study using linked registry and administrative data from National Cancer Registry (NCR), including data from the systemic anti-cancer therapy dataset (SACT) and the radiotherapy dataset (RTDS), Hospital Episode Statistics (HES), and Office for National Statistics (ONS) to evaluate the epidemiology and treatment of HR+/HER2- BC in England. Additionally, the study aims to describe access to and wastage of CDK4/6i among HR+/HER2- mBC patients.
We will include all NCR registered individuals 18 years and older with a diagnosis of HR+/HER2- BC between 1 April 2012 and 31 December 2020, or latest available data, excluding individuals with unknown sex and over 120 years old.
Outcomes include disease progression, treatment pathway, rate of discontinuation for and adherence to adjuvant therapy, demographic and regional differences in treatment and disease progression, differences in individuals treated within and outside cancer wait times, CDK4/6i dose reductions, difference in progression-free survival for CDK4/6i dose reduction, length of treatment for CDK4/6i, cycle and timepoint of CDK4/6i dose reduction, costs associated with CDK4/6i wastage, number of patients who switch CKD4/6i, time to event between stages of BC, and costs associated with BC treatment.
REC name
London - South East Research Ethics Committee
REC reference
23/PR/0961
Date of REC Opinion
30 Aug 2023
REC opinion
Favourable Opinion