A randomised trial with breast cancer and lymphoma patients to test if medication can prevent cardiac damage caused by anthracycline chemotherapy.

Phase 1

• Conditions: Myocardial toxicity and the development of left ventricular systolic dysfunction; MedDRA version: 20.1Level: LLTClassification code 10007612Term: Cardiac troponin I increasedSystem Organ Class: 100000004848; MedDRA version: 20.0Level: LLTClassification code 10069501Term: Left ventricular systolic dysfunctionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000896-99-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-04
• Study Completion: 2022-04-04
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

•Female or male aged =18 years
•Histological diagnosis of invasive breast cancer or non-Hodgkin lymphoma
•ECOG performance status 0-1
•Planned to commence anthracycline containing therapy
ofor adjuvant or neo-adjuvant treatment of breast cancer. Breast cancer patients scheduled for =300 mg/m2 cumulative dose epirubicin, or equivalent, over 3, 4 or 6 cycles
or
oNHL patients planned to commence =3 cycles of CHOP or R-CHOP therapy containing =300mg/m2 epirubicin equivalent cumulative dose of anthracycline.
•A life expectancy of at least 12 months
•LVEF = 50% on baseline MRI
•Systolic blood pressure = 105 mmHg and =170 mmHg
•An eGFR >45 mL/min/1.73 m2
•Provide written consent to take part in the study
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

•Pregnancy or breastfeeding
•HER2 positive breast disease with planned trastuzumab therapy
•Uncontrolled arterial hypertension defined as systolic blood pressure on treatment of >170 mmHg
•Patients already taking B-blockers, ACEi or ARBs
•Contra-indication to ARBs (eGFR = 45 mL/min/1.73 m2, previous hypersensitivity, renal artery stenosis) or B-blockers (asthma, pathological heart block and, pathological sinus bradycardia.
•Clinically proven intolerance to lactose monohydrate
•A history of symptomatic heart failure
•Contraindication to or inability to tolerate MRI scanning
•Suspected poor drug compliance
•Active alcohol or drug abuse
•Patients previously treated with anthracyclines or trastuzumab
•Uncontrolled concomitant serious illness, as determined by the investigator
•Female or male aged < 18 years
•Not provided written consent to take part in the study
•Previously randomised into this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether known treatments for heart failure can prevent or reduce myocardial injury and the development of left ventricular systolic dysfunction.;Secondary Objective: To establish whether a novel highly sensitive plasma marker of myocardial injury can anticipate the development and monitor progression of left ventricular systolic dysfunction.;Primary end point(s): The primary outcome measure will be a change in LVEF on cardiac MRI scan conducted 6 months after final anthracycline dose compared to baseline cardiac MRI scan conducted before anthracycline therapy starts between (randomised) treatment groups.<br>;Timepoint(s) of evaluation of this end point: Six months after the final anthracycline dose.