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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
Must not have
Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy
Current use of: Bupropion (Wellbutrin), Fluoxetine (Prozac), Paroxetine (Paxil), Quinidine (Quinidex), Duloxetine (Cymbalta), Digoxin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if carvedilol, a heart-protecting medication, is safe and effective for breast cancer patients who are at high risk of heart problems from their cancer treatments. Carvedilol helps by reducing the workload and stress on the heart.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am in heart failure needing strong IV medicine to help my heart pump.
Select...
I am currently taking medications like Wellbutrin, Prozac, Paxil, Quinidex, Cymbalta, or Digoxin.
Select...
I am currently taking a beta blocker.
Select...
I have been diagnosed with sick sinus syndrome.
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I cannot take carvedilol due to health reasons.
Select...
I am not pregnant or breastfeeding, and I have a recent negative pregnancy test.
Select...
I do not have severe slow heart rate or I have a pacemaker.
Select...
I am unable to give my consent.
Select...
My liver is not working well (high bilirubin and liver enzymes).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Left Ventricular Ejection Fraction (LVEF)
Treatment adherence as measured by pill count
Secondary study objectives
Cardiac Strain measurements by echocardiogram
Diastolic function (E/e') by echocardiogram
Frequency of individuals with clinical heart failure
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cardiotoxicity, such as beta-blockers like Carvedilol, work by reducing the heart's workload and improving its efficiency. Beta-blockers achieve this by blocking the effects of adrenaline, which slows the heart rate and lowers blood pressure.
This is particularly important for cardiotoxicity patients as it helps protect the heart from further damage caused by treatments like chemotherapy. Other treatments, including ACE inhibitors and angiotensin II receptor blockers (ARBs), also play a role by relaxing blood vessels and reducing blood pressure, thereby decreasing the heart's workload.
These mechanisms are vital for managing the heightened risk of heart failure and other cardiovascular complications in these patients.
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
464,783 Total Patients Enrolled
11 Trials studying Cardiotoxicity
1,947 Patients Enrolled for Cardiotoxicity
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,416 Total Patients Enrolled
9 Trials studying Cardiotoxicity
1,872 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your resting heart rate is below 55 beats per minute, which could indicate a serious heart condition.You are allergic to carvedilol.You have a history of asthma or similar breathing issues.I am currently taking medications like Wellbutrin, Prozac, Paxil, Quinidex, Cymbalta, or Digoxin.I am in heart failure needing strong IV medicine to help my heart pump.Your blood pressure is too low.I am currently taking a beta blocker.I have been diagnosed with sick sinus syndrome.I am 18 years old or older.I cannot take carvedilol due to health reasons.I am not pregnant or breastfeeding, and I have a recent negative pregnancy test.I do not have severe slow heart rate or I have a pacemaker.I am female.My study team can get all needed heart health info, including an echo.I have Stage I-III breast cancer and will be treated with anthracyclines or trastuzumab.You have a certain type of heart block, as shown on an electrocardiogram.I am unable to give my consent.My liver is not working well (high bilirubin and liver enzymes).
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Carvedilol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.