Can the heart drug enalapril prevent heart damage in patients with newly diagnosed breast cancer and lymphoma receiving chemotherapy?

Phase 1

• Conditions: Prevention of cardiotoxicity; MedDRA version: 20.0Level: PTClassification code 10048610Term: CardiotoxicitySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001094-16-GB
• Lead Sponsor: South Tees NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

•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;
OR
•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
AND
•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
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

•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;
•known metastatic breast cancer;
•previous exposure to anthracycline chemotherapy;
•are pregnant or breastfeeding;
•previous Herceptin treatment or planned Herceptin treatment within four weeks following anthracycline chemotherapy;
•for patients of childbearing potential: refusal to use adequate contraception throughout the trial;***
•any other invasive cancer diagnosed and treated in the past 5 years;
•symptomatic or severe asymptomatic radiation-induced cardiac disease;
•participation in other interventional medicinal trials in the past 6 months;
•judgement by the investigator that the patient has a prognosis of < 1 year or are unlikely to complete 6 cycles of chemotherapy.
•judgement by the investigator that the patient is high risk for tumour lysis syndrome (applicable only to NHL patients).
•judgement 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.

*<50% as defined by Simpson’s biplane method; if absolute measurements are not possible, then a visually normal assessment of LVEF is acceptable for inclusion.

**White coat hypertension is more common, and should be ruled out by an ambulatory blood pressure monitor

***Female patients between the ages of 18 and 50 will receive a pregnancy test at baseline.

Adequate methods of contraception are those that can achieve a failure rate of less than 1% per year when used consistently and correctly, such methods include:
•combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
ooral
ointravaginal
otransdermal
•progestogen-only hormonal contraception associated with inhibition of ovulation
ooral
oinjectable
oimplantable
•intrauterine device (IUD)
•intrauterine hormone-releasing system (IUS)
•bilateral tubal occlusion
•vasectomy/vasectomised partner
•true sexual abstinence (refraining from heterosexual intercourse during the entire period of study treatment)

Study & Design

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