Carvedilol for Cardioprotection in Breast Cancer

(CCTGuide Pilot Trial)

Overseen By Bonnie Ky, MD, MSCE

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Antidepressants, Digoxin, Beta blockers

Disqualifiers: Pregnancy, Asthma, Hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 27

Duration: 12 months

69 Participants Needed

Trial Summary

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.

Research Team

Bonnie Ky, MD, MSCE

Principal Investigator

Perelman School of Medicine at the University of Pennsylvania

Eligibility Criteria

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 18 years old or older.

I am female.

My study team can get all needed heart health info, including an echo.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Carvedilol Experimental Treatment 1 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 Care Active Control 1 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.

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+