Heart-Safe breast cancer treatment? pilot study tests preventive meds
NCT ID NCT06844669
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study aimed to see if giving heart medications (carvedilol and empagliflozin) to women starting HER2-targeted therapy for breast cancer could prevent heart damage. The study planned to enroll 20-40 participants but was terminated early after enrolling only 7. The goal was to test if this preventive approach is feasible and safe.
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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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7 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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May 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed HER2+ breast cancer by ASCO/CAP guidelines of any clinical or pathologic stage. * Planning to commence standard of care HER2-directed therapy or started HER2-directed therapy within 6 months prior to randomization * At least 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * For patients newly commencing HER2-directed therapy, left ventricular ejection fraction (LVEF) ≥ 50% up to 30 days prior to enrollment detected by echocardiogram. For patients already receiving HER2-directed therapy, LVEF ≥ 50% after the last cycle of therapy prior to enrollment. (Patient will be enrolled at the time of their next cycle after the echocardiogram.) * Systolic blood pressure ≥ 100 mmHg and resting heart rate ≥ 60 bpm. * eGFR \> 30 mL/min/1.73m\^2. * Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Patients with an acceptable support system (as determined by the treating medical team). * Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: * Prior exposure to mantle cell lymphoma field radiation. * Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the treating physician. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial. * Currently receiving treatment with SGLT2i or BB that cannot be stopped during the duration of study participation. Currently receiving non-dihydropyridine calcium channel blocker that cannot be transitioned to or used in combination with carvedilol. * Patients with untreated brain metastases requiring central nervous system directed therapy and interruption of systemic HER2 directed therapy (as determined by the treating medical team. * A known history of allergic reactions attributed to compounds of similar chemical or biologic composition to carvedilol, empagliflozin, or other agents used in the study. * Contraindication to carvedilol or empagliflozin at the discretion of the investigator such as: * Bronchial asthma or related bronchospastic conditions where BB would be contraindicated * Second- or third-degree atrioventricular (AV) block * Sick sinus syndrome * Severe bradycardia (unless permanent pacemaker in place) * In cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy * Severe hepatic impairment in setting of cirrhosis that prevents use of carvedilol * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or uncontrolled cardiac arrhythmia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
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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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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new antibody boost treatment for Hard-to-Treat HER2 breast cancer?
- Can a PI3K inhibitor boost presurgery breast cancer treatment?
- Can a platform trial match the right drug combo to each tumor?
- Can a shorter treatment hold off small HER2-Positive breast cancers?
- Can a Double-Pronged antibody outsmart HER2-Positive tumors?
- Can a vaccine teach the immune system to fight HER2-Positive tumors?