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ACTIVE NOT RECRUITING
NCT06844669
PHASE2

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

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: HER2HEART-US: Primary Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy: a Pilot 2x2 Factorial Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2025-04-16

Completion Date

2026-05-05

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

Carvedilol

6.25 mg with food

DRUG

Empagliflozin

10 mg in the morning with or without food

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States