Status:
COMPLETED
PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?
Lead Sponsor:
South Tees Hospitals NHS Foundation Trust
Collaborating Sponsors:
Newcastle University
University of Durham
Conditions:
Breast Cancer
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI) enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer and non-Hodgkin ...
Detailed Description
PROACT is a phase 3 randomised, open label, blinded endpoint, superiority trial of enalapril to prevent anthracycline-induced in patients treated for breast cancer and lymphoma. Anthracyclines used i...
Eligibility Criteria
Inclusion
- Written informed consent.
- 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 540mg/m2 epirubicin) or FEC 75 (total planned dose 450mg/m2 epirubicin) adjuvant chemotherapy regimen. Patients with HER2+ breast cancer are eligible for inclusion.
- OR
- Adult patients with histopathologically confirmed non-Hodgkin lymphoma (NHL), planned to receive 6 cycles of R-CHOP or CHOP (total planned dose 300mg/m2 doxorubicin) chemotherapy\*\*
- Patients with HER2+ breast cancer are eligible for inclusion. \*\* Patients who will receive an alternative anti-CD20 monoclonal antibody are eligible (for example O-CHOP), as long as the total planned doxorubicin dose is ≥300mg/m2 over 6 cycles
Exclusion
- 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;
- 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
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomy/vasectomised partner
- true sexual abstinence
Key Trial Info
Start Date :
October 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2023
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT03265574
Start Date
October 4 2017
End Date
August 4 2023
Last Update
February 20 2024
Active Locations (1)
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1
South Tees Hospitals NHS FT
Middlesbrough, Teesside, United Kingdom, TS4 3BW