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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met