69 Participants Needed

Carvedilol for Cardioprotection in Breast Cancer

(CCTGuide Pilot Trial)

BK
Overseen ByBonnie Ky, MD, MSCE
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

BK

Bonnie Ky, MD, MSCE

Principal Investigator

Perelman School of Medicine at the University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carvedilol in a risk-guided strategy alongside doxorubicin and/or trastuzumab

12 months
Visits at baseline and approximately 3, 6, 9, 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at approximately 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carvedilol
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials
360
Recruited
108,000+
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