Clinical trial · Interventional
Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure
TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual; insufficient funding to continue to accrue
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carvedilol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pre-Emptive Strategy
- description
- Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated one week before start of therapy and continued until end of therapy
- interventionNames
- Drug: Carvedilol
- type
- EXPERIMENTAL
- label
- Reactive Strategy
- description
- Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated after documentation of subclinical cardiotoxicity, defined by an abnormal global longitudinal strain (GLS) or high-sensitive cardiac troponin (hsTnI) elevation and continued until end of therapy
- interventionNames
- Drug: Carvedilol
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available