Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure
Reason given: slow accrual; insufficient funding to continue to accrue
Key facts
- Where
- Houston, Jacksonville, Phoenix, Rochester, and St Louis, United StatesSee the 5 sites
- Phase
- Phase 2
Where in United States
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Mayo Clinic in FloridaJacksonville, United StatesNo longer taking part
- Mayo ClinicPhoenix, United StatesNo longer taking part
- Mayo Clinic in RochesterRochester, United StatesNo longer taking part
- Washington University in St. LouisSt Louis, United StatesNo longer taking part
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT03879629
- Record updated
- 15 June 2026
- Original description
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.Read full original descriptionShow less
TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC) Trial
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.
Inclusion: ≥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: on active therapy with amiodarone, sotalol, or any other antiarrhythmic; Diagnosis of asthma with current daily use of anti-asthmatic therapy; history of HF of any class and type, or diagnosis of cardiomyopathy in the past,; 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,; heart rate < 50 BPM at screening (average of 3 most recent readings); history of or current sick sinus syndrome,; Metastatic breast cancer (distant metastases); Active systemic treatment for non-breast cancer; LVEF <50% at screening,; severe hepatic dysfunction, as defined by NCI ODWG (total bilirubin >3x ULN, any AST elevation) or Child Pugh C class; intolerance to beta-blocker,; 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); pregnancy.