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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06844669
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carvedilol — DRUG
    6.25 mg with food
  • Empagliflozin — DRUG
    10 mg in the morning with or without food

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
May 2026
Primary completion
Feb 16, 2026
Completion
May 7, 2026

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm 1: Carvedilol BID
    Carvedilol by mouth twice per day (BID) for 12 weeks.
  • Experimental: Arm 2: Empagliflozin QD
    Empagliflozin by mouth daily (QD) for 12 weeks.
  • Experimental: Arm 3: Carvedilol BID + Empagliflozin QD
    Carvedilol by mouth twice per day (BID) for 12 weeks and empagliflozin by mouth daily (QD) for 12 weeks.
  • No Intervention: Arm 4: Usual Care
    No medications.

Primary Outcome Measure

Feasibility of HER2HEART as measured by the number of patients enrolled over a 10-month period [ Time Frame: 10 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Washington University School of Medicine· St Louis, MO

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