Status: Open
Specialty: Lyphoma/Breast
Date Opened: 29/06/2021
Planned Close Date: 30/11/2022
Sponsor: Cancer Research UK
Principal Investigator: Dr Macheta
Breast cancer is the most common type of cancer amongst women worldwide, with over 50,000 new cases in the UK every year. Treatment often includes surgery, chemotherapy and radiotherapy and is highly effective.
However, the chemotherapy commonly given is a type called anthracyclines, which can cause damage to the heart cells. This may in turn lead to poorer heart function and heart failure.
In this study, we would like to understand if a commonly used heart drug called enalapril can stop patients who are receiving anthracycline-based chemotherapy for their breast cancer from getting heart damage.
• Adult patients with histopathologically confirmed breast carcinoma who have received surgery for their breast cancer (including patients with HER2+ breast cancer);
• planned to receive a 6 cycle adjuvant chemotherapy regimen containing > 300mg / m2 of epirubicin;
• Written informed consent
• Positive baseline cardiac troponin T ( > = 14ng / L);
• known contraindication to ACE inhibitor e.g. renal artery stenosis, severe aortic stenosis;
• are taking, or have a previous intolerance to ACEI (e.g. angioedema);
• patient already taking other agents acting on the renin-angiotensin-aldosterone system e.g. Aliskerin, angiotensin receptor blockers (ARBs), Entresto (sacubitril / valsartan), spironolactone, eplerenone;
• LVEF < 50%;
• estimated GFR < 30 mL / min / 1.73m2 at baseline ;
• hyperkalaemia defined as serum potassium > = 5.5mmol / L;
• symptomatic hypotension, or Systolic Blood Pressure < 100mmHg;
• poorly controlled hypertension (Blood Pressure > 160 / 100mmHg**, or ambulatory BP of 150 / 95mmHg);
• previous myocardial infarction;
• known metastatic breast cancer;
• previous exposure to anthracycline chemotherapy;
• are pregnant or breastfeeding
• Herceptin planned treatment within four weeks following anthracycline chemotherapy
• For patients of childbearing potential: refusal to use adequate contraception throughout the trial;
• any other cancer diagnosis;
• judgment by the Investigator that the patient should not participate in the study, for example, if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Research Nurse: Nicola Slawson (Ext No. 53062) Nicola.Slawson@nhs.net
Administrator: Tamaryn Louw
Link to EDGE