Investigating the long-term cardiac sequelae of trastuzumab therapy
Research type
Research Study
Full title
Investigating the long-term cardiac sequelae of trastuzumab therapy
IRAS ID
272393
Contact name
Kenneth Mangion
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The aim of this study is to investigate the ‘late’ prevalence of left ventricular (LV) dysfunction in patients treated for breast cancer with trastuzumab at least five years previously.
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes. However, cardiac toxicity remains a substantial concern. Conventionally, this toxicity has been considered as a transient and reversible phenomenon occurring in the immediate peri-treatment period. Recent data suggest that trastuzumab-related cardiotoxicity may also manifest in the longer-term. However, this concern has not been adequately addressed and the longer-term prevalence of left ventricular dysfunction with HER2 positive breast cancer treated with trastuzumab is unclear.
The aim of this project is to define the prevalence of left ventricular dysfunction late after completion of trastuzumab therapy will help to clarify the need and optimal surveillance methods to detect cardiac dysfunction in these patients.
Participants will be identified from a dedicated oncology database from the Beatson West of Scotland Cancer Centre who received anthracycline and trastuzumab chemotherapy at least 5 years previously. Participants will undertake a health questionnaire (EQ5D), a detailed medical history, a 12-lead ECG, blood tests including cardiac biomarkers (high sensitivity troponin, NT-proBNP), lipid profile, renal function, and a non-invasive blood pressure measurement. Cardiac function and pathology will be investigated by a multiparametric cardiac magnetic resonance imaging (CMR) scan.
Additionally, data generated here will be used to inform controlled trials of cardio-protective therapy to reduce potential ‘late’ trastuzumab toxicity.
Sex and age matched healthy volunteers will undergo a similar CMR scan.REC name
West of Scotland REC 3
REC reference
20/WS/0011
Date of REC Opinion
26 Feb 2020
REC opinion
Further Information Favourable Opinion