HER-SAFE
Research type
Research Study
Full title
Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction
IRAS ID
312432
Contact name
Charlotte Manisty
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
Breast cancer is the most common cancer in the UK, but improvements in treatment mean 3 in 4 people survive for more than 10 years. Many people receive treatments called HER2-targeted therapies for their breast cancer, however these can affect heart function. This ‘cardiotoxicity’ is generally temporary and mild, but patients receive drugs to help their heart recover. Currently we don’t know how long patients should receive these treatments. Patients with other types of heart failure are treated lifelong, but this may not be necessary here as the damaging cancer drugs have stopped. Taking drugs for many years can have an impact on people’s quality of life, particularly for young patients. It is therefore important to understand the best treatment length. We will study people whose heart function has recovered after HER2 therapy heart problems and are not at high risk for heart disease. We will carefully stop their heart drugs whilst monitoring them closely with special heart scans and blood tests to detect problems early. We will also study how patients are currently treated using national data. The results of this study will help doctors better guide breast cancer survivors about treatment of heart damage from HER2 cancer therapies.
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0152
Date of REC Opinion
28 Feb 2023
REC opinion
Favourable Opinion