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Carvedilol for Cardiomyopathy in Breast Cancer Patients (TACTIC Trial)

Phase 2
Recruiting
Led By Joerg Herrmann
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Planned HER2-directed therapy (any therapy targeting HER2 signaling including Trastuzumab +/- pertuzumab or trastuzumab-emtansine (T-DM1) Nerantinib and lapatinib will not be considered)
Must not have
Current ACE inhibitor or ARB therapy for hypertension in the presence of diabetes and/or for chronic kidney disease/proteinuria
On active therapy with amiodarone, sotalol, or any other antiarrhythmic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing whether a beta blocker called carvedilol can help protect the hearts of breast cancer patients taking trastuzumab-based HER2-directed therapy, either by starting it when significant heart function decline or early signs of heart injury are noted, or preventatively before beginning trastuzumab-based therapy.

Who is the study for?
This trial is for adults over 18 with a new or recurring HER2+ breast cancer, treated with curative intent and planned HER2-directed therapy. It's not for those with past heart failure/cardiomyopathy, low heart function at screening, certain blood pressure/heart rhythm issues, severe liver dysfunction, pregnancy, metastatic breast cancer or intolerance to beta-blockers.
What is being tested?
The study tests if the beta-blocker carvedilol can protect the heart when given during trastuzumab-based HER2-directed therapy for breast cancer. Participants are randomly assigned to start carvedilol either after early signs of heart injury or preventatively before treatment. They may continue or stop taking it after completing trastuzumab therapy.
What are the potential side effects?
Carvedilol may cause dizziness, fatigue, low blood pressure, slower heartbeat rate and other cardiovascular effects. Some people might experience digestive disturbances or breathing difficulties if they have a history of asthma.

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 scheduled for a treatment targeting HER2, excluding Nerantinib and Lapatinib.
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I have a new or returning HER2+ breast cancer and plan to treat it to cure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking ACE inhibitors or ARBs for high blood pressure, diabetes, or kidney disease.
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I am currently taking medication for heart rhythm problems.
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I have a history of heart failure or have been diagnosed with cardiomyopathy.
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I am taking beta-blockers for heart disease.
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I have asthma and use daily asthma medication.
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I am currently receiving treatment for a cancer that is not breast cancer.
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My breast cancer has spread to distant parts of my body.
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I have or had a condition where my heart beats irregularly.
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I have severe liver problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of asymptomatic and symptomatic cardiac dysfunction
Rate of reversible cardiac function decline
Secondary study objectives
Cardiac function changes after completion of HER2-directed therapy
Gene variants and risk of cardiotoxicity and response to therapy

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Reactive StrategyExperimental Treatment1 Intervention
Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated after documentation of subclinical cardiotoxicity, defined by an abnormal global longitudinal strain (GLS) or high-sensitive cardiac troponin (hsTnI) elevation and continued until end of therapy
Group II: Pre-Emptive StrategyExperimental Treatment1 Intervention
Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated one week before start of therapy and continued until end of therapy
Group III: Standard of CareActive Control1 Intervention
Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated after documentation of a drop in LVEF by \>10% to a value less than 53% and continued until end of therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
2011
Completed Phase 4
~1410

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,957,995 Total Patients Enrolled
83 Trials studying Breast Cancer
14,346 Patients Enrolled for Breast Cancer
Miami Heart Research InstituteUNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,550 Total Patients Enrolled
944 Trials studying Breast Cancer
1,543,514 Patients Enrolled for Breast Cancer

Media Library

Carvedilol Clinical Trial Eligibility Overview. Trial Name: NCT03879629 — Phase 2
Breast Cancer Research Study Groups: Pre-Emptive Strategy, Reactive Strategy, Standard of Care
Breast Cancer Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT03879629 — Phase 2
Carvedilol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03879629 — Phase 2
~181 spots leftby Feb 2028
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