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Carvedilol for Cardioprotection in Breast Cancer (CCTGuide Pilot Trial)

Phase 1

Waitlist Available

Led By Bonnie Ky, MD, MSCE

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old

Females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

CCTGuide Pilot Trial Summary

This trial will compare the effects of a heart-protective drug (carvedilol) to usual care in breast cancer patients being treated with doxorubicin, trastuzumab, or both.

Who is the study for?

This trial is for women over 18 with Stage I-III breast cancer who are about to receive anthracyclines and/or trastuzumab. They must have a measurable heart function score and not be pregnant or breastfeeding. Exclusions include asthma, current beta blocker use, low blood pressure, certain heart conditions, severe liver issues, and use of specific medications.Check my eligibility

What is being tested?

The study tests if Carvedilol can protect the hearts of breast cancer patients from damage caused by chemotherapy drugs like doxorubicin and trastuzumab. It's compared to usual care without Carvedilol to see if it's safe and tolerable.See study design

What are the potential side effects?

Carvedilol may cause side effects such as dizziness due to low blood pressure, tiredness, changes in weight or mood swings. Some people might experience more serious issues like worsening symptoms of heart failure or severe allergic reactions.

CCTGuide Pilot Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am female.

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I have Stage I-III breast cancer and will be treated with anthracyclines or trastuzumab.

CCTGuide Pilot Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Left Ventricular Ejection Fraction (LVEF)

Treatment adherence as measured by pill count

Secondary outcome measures

Cardiac Strain measurements by echocardiogram

Diastolic function (E/e') by echocardiogram

Frequency of individuals with clinical heart failure

+3 more

CCTGuide Pilot Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CarvedilolExperimental Treatment1 Intervention

Carvedilol will be initiated at 3.125mg twice daily and uptitrated as tolerated in a stepwise fashion to a maximum dose of 25mg twice daily or to a systolic blood pressure (SBP) of 110-120mmHg or heart rate (HR) of 50-55 beats per minute (bpm). Patients will start carvedilol in the evening after first dose of chemotherapy and will continue on medication for 12 months. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and standardized time intervals during and after therapy at approximately 3, 6, 9, 12, and 24 months.

Group II: Usual CareActive Control1 Intervention

Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and standardized time intervals during and after therapy at approximately 3, 6, 9, 12, and 24 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carvedilol

2011

Completed Phase 4

~1410

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,626 Total Patients Enrolled

11 Trials studying Cardiotoxicity

1,993 Patients Enrolled for Cardiotoxicity

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,026 Total Patients Enrolled

9 Trials studying Cardiotoxicity

1,918 Patients Enrolled for Cardiotoxicity

Bonnie Ky, MD, MSCEPrincipal InvestigatorPerelman School of Medicine at the University of Pennsylvania

5 Previous Clinical Trials

897 Total Patients Enrolled

5 Trials studying Cardiotoxicity

897 Patients Enrolled for Cardiotoxicity

Media Library

Carvedilol Clinical Trial Eligibility Overview. Trial Name: NCT04023110 — Phase 1

Cardiotoxicity Research Study Groups: Usual Care, Carvedilol

Cardiotoxicity Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT04023110 — Phase 1

Carvedilol 2023 Treatment Timeline for Medical Study. Trial Name: NCT04023110 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What core goals are this research project trying to achieve?

"This medical trial will be assessing the Left Ventricular Ejection Fraction (LVEF) of patient's over a one-year period. Secondary outcomes being monitored include changes in N-terminal pro B-type natriuetic peptide (NTproBNP), ventricle to artery coupling as derived from echocardiography, and High-sensitivity Troponin (hsTnT)."

Answered by AI

Has Carvedilol received official sanction from the FDA?

"Carvedilol's safety profile is based on the initial evidence collected during Phase 1 trials, so our team gave it a low rating of 1."

Answered by AI

Are there any open slots available for this research trial?

"The clinical trials registry on the website affirms that this particular medical trial is no longer taking in participants. The project was initially posted on August 9th 2019, and last modified on October 14th 2022. Notwithstanding, there are still 3,542 other studies actively searching for candidates to enrol."

Answered by AI

What is the cap on how many individuals can partake in this research?

"At this time, no additional candidates are being accepted for the trial that was first posted on August 9th 2019 and last updated October 14th 2022. However, if you seek other trials related to cardiomyopathies there are currently 3514 studies recruiting participants and 28 clinical trials using Carvedilol as an intervention actively enrolling patients."

Answered by AI

To what ailments is Carvedilol regularly prescribed?

"Carvedilol is a medication often recommended to treat hypertensive disease, heart failure, and hypesthesia."

Answered by AI

Can you provide a detailed overview of the other experiments conducted using Carvedilol?

"Currently, 28 ongoing trials for Carvedilol are underway with 7 in their final phase. While Orlando, Florida is a hub for these studies, 976 additional locations across the globe have been enlisted to partake in this clinical investigation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab

2019. "Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04023110.

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