Heart shield for breast cancer patients: Beta-Blocker may prevent Chemo-Induced damage
NCT ID NCT03879629
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether the beta-blocker carvedilol can prevent or treat heart problems in breast cancer patients receiving HER2-targeted therapy. About 184 adults with HER2-positive breast cancer will be randomly assigned to take carvedilol either preventatively or only after signs of heart injury appear. The goal is to find the best timing and duration for heart protection during cancer treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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224 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Mayo Clinic
Phoenix, Arizona, 85054, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Washington University in St. Louis
St Louis, Missouri, 63110, United States
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