Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure
Stopped early · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03879629
- Run by
- Mayo Clinic
- People needed
- 224
- Starts
- 2019-08-21
- Expected to finish
- 2026-02-28
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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".
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Phoenix, Arizona, United States
- Mayo Clinic in Florida — Jacksonville, Florida, United States
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
- Washington University in St. Louis — St Louis, Missouri, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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