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NCT04023110 · ClinicalTrials.gov registry record · Phase 1
Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
A Phase 1 study of Breast Cancer and Heart Failure, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT04023110: Completed Phase 1 study of Breast Cancer and Heart Failure, sponsored by Abramson Cancer Center at Penn Medicine.
NCT04023110 is a Phase 1 study of Breast Cancer and Heart Failure that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 68 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04023110, a Phase 1 study of Breast Cancer and Heart Failure, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
Investigators will evaluate the safety, tolerability, and feasibility of a risk-guided cardioprotective treatment strategy with carvedilol, as compared to usual care, in breast cancer patients undergoing treatment with doxorubicin, trastuzumab, or the combination.
Primary Outcome
LVEF by echocardiogram. Left ventricular ejection fraction (LVEF) is defined as the left ventricular stroke volume (left ventricular end diastolic volume minus the left ventricular end systolic volume) divided by the left ventricular end diastolic volume. This fraction is multiplied by 100 to yield the LVEF, and is defined as a % (the unit of measure) (J Am Soc Echocardiogr 2015;28:1-39.). 2D left ventricular volumes are estimated according to the biplane method of disks (modified Simpson's rule
Conditions Studied
Interventions
- DRUG Carvedilol
Study Locations (1)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2019-08-09 |
| Est. Completion | 2025-01-14 |
| Phase | Phase 1 |
What the finished NCT04023110 record still lists
NCT04023110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Carvedilol is the first listed.
NCT04023110 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04023110 about?
NCT04023110 is a clinical study titled "Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab". Investigators will evaluate the safety, tolerability, and feasibility of a risk-guided cardioprotective treatment strategy with carvedilol, as compared to usual care, in breast cancer patients undergoing treatment with doxorubicin, trastuzumab, or the combination.
What is the current status of trial NCT04023110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2019-08-09. Estimated completion is 2025-01-14.
What conditions does trial NCT04023110 study?
This clinical trial studies the following conditions: Breast Cancer, Heart Failure, Cardiomyopathies, Cardiotoxicity, Risk Factor, Cardiovascular.
What interventions are being tested in trial NCT04023110?
The interventions under investigation include: Carvedilol (DRUG).
Who is sponsoring clinical trial NCT04023110?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04023110 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT04023110's enrollment target sits among peer trials
68 706th of 1224 higher than 509 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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