HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy

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.