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This study examines the use of Carvedilol to reduce the occurrence of heart failure in patients receiving trastuzumab for HER2-positive breast cancer. It included patients aged 18 and older who were planned to receive HER2-directed therapy with curative intent and had no prior history of heart failure. It was conducted in Phase 2 and is currently active but not recruiting new participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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