Ten to 15% of patients with breast cancer are HER2 positive, with treatment focused on targeting the HER2 receptor. Although these treatments are generally well tolerated, they are associated with an increased risk of cardiomyopathy. There are currently no treatments proven to prevent the cardiotoxicities associated with HER2-targeted therapy, but there is convincing preclinical data demonstrating that prophylactic treatment with a beta blocker (BB) and/or an SGLT2 inhibitor (SGLT2i) may each independently prevent cardiotoxicity and HER-targeted treatment interruptions. The proposed pilot study will assess the feasibility and preliminary efficacy and safety of therapy with both a beta blocker (carvedilol) and an SGLT2 inhibitor (empagliflozin), alone and in combination, in a population initiating HER2-directed therapy for HER2+ breast cancer. The hypotheses being tested in this study are: 1. It is feasible to recruit 20-40 patients over 6 months 2. There are no differences in tolerability and safety between participants taking carvedilol and/or empagliflozin and those receiving usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
7
6.25 mg with food
10 mg in the morning with or without food
Washington University School of Medicine
St Louis, Missouri, United States
Feasibility of HER2HEART as measured by the number of patients enrolled over a 10-month period
Feasibility is defined as enrollment of 20-40 patients (5-10 per am) over a 10-month recruitment period.
Time frame: 10 months
Tolerability as measured by treatment adherence via self-report
Time frame: From start of treatment through last day of study treatment (estimated to be 3 months)
Tolerability as measured by incidence of serious adverse events
Time frame: From start of treatment through last day of study treatment (estimated to be 3 months)
Tolerability as measured by incidence of adverse events of special interest
* Symptomatic hypotension (systolic blood pressure \<90 mmHg) * Symptomatic bradycardia (heart rate \<50 bpm) * Acute renal dysfunction (eGFR decrease \>30% from baseline) * Syncope * Symptomatic hypoglycemia (blood glucose \<70 mg/dL) * Perineal infection * Urinary tract infection * Diabetic ketoacidosis (commonly accepted criteria are blood glucose \> 250 mg/dL, arterial pH \< 7.3, serum bicarbonate \< 15 mEq/L, and the presence of ketonemia or ketonuria). * Euglycemic diabetic ketoacidosis (diabetic ketoacidosis in the absence of hyperglycemia)
Time frame: From start of treatment through last day of study treatment (estimated to be 3 months)
Tolerability as measured by number of participants who withdraw from the study due to adverse events
Time frame: From start of treatment through last day of study treatment (estimated to be 3 months)
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