Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Car… (NCT05880160) | Clinical Trial Compass
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Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction
United Kingdom90 participantsStarted 2023-07-14
Plain-language summary
Breast cancer is the most common cancer in the United Kingdom (UK), but improvements in treatment mean 3 in 4 people survive for more than 10 years. Many people receive treatments called human epidermal growth factor receptor 2 (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 it is not known 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. The investigators will study people whose heart function has recovered after HER2 therapy heart problems and are not at high risk for heart disease. The investigators will carefully stop their heart drugs whilst monitoring them closely with special heart scans and blood tests to detect problems early. The investigators 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult participants (\>18 years)
✓. A prior diagnosis of human epidermal growth factor receptor 2 (HER2)- targeted therapy related cardiac dysfunction, who currently receive standard heart failure/cardioprotective medications (any combination of angiotensin-converting enzyme \[ACE\] inhibitors, angiotensin receptor blockers \[ARBs\] and/or beta-blockers).
✓. Cardiac function has 'recovered'. 'Recovery' is defined as absence of heart failure symptoms with left ventricular ejection fraction (LVEF) improved to 50% or greater and N-terminal pro B-type natriuretic peptide (NTproBNP) \<125ng/L, for greater than 6 months.
Exclusion criteria
✕. Advanced/ metastatic HER2 positive breast cancer requiring ongoing HER2 therapies or with life expectancy \<12months.
✕. Patients classed as high/very high cardiovascular risk according to the International Cardio-Oncology Society (ICOS) risk stratification
✕. Patients with LVEF \<50% prior to HER2-therapy initiation or on completion of anthracycline treatment
✕. Patients with ongoing indications for the cardioprotective medication - ACE inhibitors, ARBs and/or beta-blockers