Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incide… (NCT03879629) | Clinical Trial Compass
TerminatedPhase 2
Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure
Stopped: slow accrual; insufficient funding to continue to accrue
United States224 participantsStarted 2019-08-21
Plain-language summary
Breast cancer patients undergoing trastuzumab-based HER2-directed therapy are at risk of heart function decline or heart failure symptoms, but it is unknown if, when, and for how long cardiovascular protective strategies, e.g. with a beta-blocker, could help. This study randomly assigns those taking curative-intent trastuzumab-based HER2-directed therapy to the beta-blocker carvedilol-either when significant heart function decline or subtle early signs of heart injury (either by elevation of a cardiac blood biomarker, i.e. cardiac troponin, or by an abnormal heart ultrasound marker, i.e. global longitudinal strain) are noted, or preventatively before beginning trastuzumab-based HER2-directed therapy. This study will further randomly assign those patients on carvedilol to either discontinuation at the end of trastuzumab-based HER2-directed therapy or continuation for another year, providing much needed clinical trial data on what the best strategy ("tactic") for those at risk of cardiotoxicity with trastuzumab-based HER2-directed therapy is.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 years of age,
* new or locally recurrent diagnosis of HER2+ breast cancer that will be treated with curative intent
* planned HER2-directed (any therapy targeting HER2 signaling including Trastuzumab +/- pertuzumab or trastuzumab-emtansine (T-DM1) Nerantinib and lapatinib will not be considered. "HER2-directed therapy" or "anti-HER-2".
Exclusion Criteria:
* history of HF of any class and type, or diagnosis of cardiomyopathy in the past,
* LVEF \<50% at screening,
* intolerance to beta-blocker,
* baseline use of any beta-blocker for coronary artery disease including myocardial infarction
* current ACE inhibitor or ARB therapy for hypertension in the presence of diabetes and/or for chronic kidney disease/proteinuria,
* on active therapy with amiodarone, sotalol, or any other antiarrhythmic
* Diagnosis of asthma with current daily use of anti-asthmatic therapy
* heart rate \< 50 BPM at screening (average of 3 most recent readings)
* history of or current sick sinus syndrome,
* AV block grade II or higher (unless patient has a permanent pacemaker) at screening,
* systolic blood pressure \< 90 mmHg at screening (average of 3 most recent readings)
* severe hepatic dysfunction, as defined by NCI ODWG (total bilirubin \>3x ULN, any AST elevation) or Child Pugh C class
* pregnancy
* Metastatic breast cancer (distant metastases)
* Active systemic treatment for non-breast cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of asymptomatic and symptomatic cardiac dysfunction