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NCT06844669 · ClinicalTrials.gov registry record · Phase 2
HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy
A Phase 2 study of HER2-positive Breast Cancer and HER2 + Breast Cancer, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT06844669: Active Phase 2 study of HER2-positive Breast Cancer and HER2 + Breast Cancer, sponsored by Washington University School of Medicine.
NCT06844669 is a Phase 2 study of HER2-positive Breast Cancer and HER2 + Breast Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 7 participants, below the 236-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06844669, a Phase 2 study of HER2-positive Breast Cancer and HER2 + Breast Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Feasibility is defined as enrollment of 20-40 patients (5-10 per am) over a 10-month recruitment period.
Conditions Studied
Interventions
- DRUG Carvedilol
- DRUG Empagliflozin
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2025-04-16 |
| Est. Completion | 2026-05-05 |
| Phase | Phase 2 |
What the registry record for NCT06844669 still lists
NCT06844669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 236-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Carvedilol is the first listed.
NCT06844669 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06844669 about?
NCT06844669 is a clinical study titled "HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy". 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 cardiotoxi...
What is the current status of trial NCT06844669?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2025-04-16. Estimated completion is 2026-05-05.
What conditions does trial NCT06844669 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, HER2 + Breast Cancer.
What interventions are being tested in trial NCT06844669?
The interventions under investigation include: Carvedilol (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT06844669?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06844669 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06844669's enrollment target sits among peer trials
7 59th of 58 the lowest of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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