PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With B... | Recruiting
PROACT: Can we Prevent Chemotherapy... | Recruiting
PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer?
PROACT

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Medical Conditions
  • Breast Cancer
Primary Contact Details
David Austin
55909 01642 850850
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT03265574
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI) enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer undergoing adjuvant epirubicin-based chemotherapy.
Research Details
  • PROACT is a phase 3 randomised, open label, blinded endpoint, superiority trial of enalapril to prevent anthracycline-induced cardiotoxicity.

    Anthracyclines used in the treatment of breast cancer cause damage to heart muscle cells; this results in cell death (cardiotoxicity). In UK contemporary practice, epirubicin is the most frequently used anthracycline.

    Patients due to receive adjuvant anthracycline chemotherapy (planned epirubicin dose >300mg/m2) for breast cancer at four specialist centres in the North of England will be invited to participate. 170 eligible patients will be randomised in a 1:1 ratio, to either enalapril plus usual care or to usual care. Enalapril will be commenced prior to the first anthracycline dose, titrated to a maximum tolerated dose, and continued during chemotherapy. Chemotherapy will continue per usual care; typically six treatment cycles. Patients will have a blood test performed at the end of each chemotherapy cycle to measure cardiac troponin, and at one month following the last epirubicin dose. Investigators and patients will be blinded to the troponin results. Patients will have an echocardiogram at baseline and following their chemotherapy; they will be assessed in a blinded manner by a central Core Laboratory.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Enalapril

Study Arm Groups : Intervention

Intervention Type
See Interventions above
Primary Outcome Measures
    Cardiac troponin T release; One month after last dose of epirubicin
Secondary Outcome Measures
    Cardiac function; One month after last dose of epirubicin; Adherence to enalapril; One month after last dose of epirubicin; Adverse Events / Reactions; One month after last dose of epirubicin; Anxiety or distress related to trial participation; One month after last dose of epirubicin; Cancer and chemotherapy outcomes; One month after last dose of epirubicin
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
170
Participant Inclusion Criteria
    Inclusion Criteria:

    - Adult patients with histopathologically* confirmed breast carcinoma who have received surgery for their breast cancer;

    - planned to receive a 6 cycle adjuvant chemotherapy regimen containing >300mg/m2 of epirubicin;

    - Written informed consent. *Patients with HER2+ breast cancer are eligible for inclusion.

    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

    - 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.

    *<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

    - double-barrier contraception (condom and occlusive cap e.g., diaphragm or cervical cap with spermicide)

    - true sexual abstinence
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
South Tees Hospitals NHS FT
Middlesbrough
Teesside
TS4 3BW
Trial Contact(s)
Primary Trial Contact
David Austin
55909 01642 850850
Other Trial Contacts
Lisa Chang, PhD
0191 334 0324
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Preventing Cardiac Damage in Patients Treated for Breast Cancer: a Phase 3 Randomised, Open Label, Blinded Endpoint, Superiority Trial of Enalapril to Prevent Anthracycline-induced CardioToxicity
EudraCT Number
Not available for this trial
Funder(s)
  • Newcastle University
  • University of Durham
  • Newcastle-upon-Tyne Hospitals NHS Trust
Other Study ID Numbers
2016152
Sponsor(s)
South Tees Hospitals NHS Foundation Trust
Key Dates

Recruitment Start Date

Sep 2017

Recruitment End Date

Sep 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

24 Aug 2017

Date updated in source

10 Nov 2017