Preventing cardiac damage in patients treated for breast cancer and lymphoma: a phase 3Randomised, Open label, blinded endpoint, trial of enalapril to preventAnthracycline-induced CardioToxicity (PROACT). - Preventing Cardiotoxicity in Patients with Breast Cancer: PROACT

South Tees NHS Foundation Trust0 sites170 target enrollmentMay 10, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 10, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

South Tees NHS Foundation Trust

•Adult patients with histopathologically\* confirmed breast carcinoma who have received surgery for their breast cancer;
•Planned to receive 6 cycles of EC 90 (total planned dose 540 mg/m2 epirubicin) or FEC 75 (total planned dose 450 mg/m2 epirubicin) adjuvant chemotherapy regimen;
•Adult patients with histopathologically confirmed non\-Hodgkin lymphoma planned to receive 6 cycles of R\-CHOP or CHOP (total planned dose 300mg/m2 doxorubicin) chemotherapy
•Written informed consent.
•\*Patients with HER2\+ breast cancer are eligible for inclusion.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 85
•F.1\.3 Elderly (\>\=65 years) yes

•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. Aliskiren, 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;