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Carvedilol for Heart Protection in Breast Cancer Patients

Phase 2

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens

Pathology report must include HER2 expression, estrogen and progesterone receptor status

Must not have

Patients who have ever taken BB/ACE therapy are excluded

Metastatic breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new way to prevent heart problems in breast cancer patients who are at risk for developing them from their chemotherapy.

Who is the study for?

This trial is for women over 18 with early-stage HER2-positive breast cancer (Stages I-III) who are about to start treatment with specific chemotherapies known to affect the heart. They must have normal heart function and agree to use contraception. Excluded are those with severe pre-existing heart conditions, certain other health issues like severe asthma or liver dysfunction, pregnant/breastfeeding women, and anyone previously on beta-blockers.

What is being tested?

The study tests whether Carvedilol, a beta-blocker medication, can prevent or delay heart damage in patients receiving chemotherapy that's tough on the heart. Patients' hearts will be monitored using advanced imaging techniques to detect early signs of strain or damage during their cancer treatment.

What are the potential side effects?

Carvedilol may cause dizziness, fatigue, low blood pressure, slower heartbeat rate and sometimes symptoms like difficulty breathing if you have asthma. It's important for patients not already experiencing significant cardiac issues as it could worsen them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for treatment with anthracycline, trastuzumab, or pertuzumab.

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My pathology report includes HER2, estrogen, and progesterone status.

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I have no heart symptoms or only get short of breath after walking two blocks.

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I am over 18 and have early stage (I-III) breast cancer with high HER2.

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My heart's pumping ability is normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never taken BB/ACE therapy.

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My breast cancer has spread to other parts of my body.

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My heart's pumping ability is reduced.

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I experience heart failure symptoms with minimal activity or at rest.

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I have a very slow heartbeat (<50 bpm) or very low blood pressure (<85 mmHg).

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My liver is severely impaired.

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I have a serious heart condition.

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I have been diagnosed with sick sinus syndrome.

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I have moderate to severe asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Global Longitudinal Strain

Secondary study objectives

Number of cancer treatments

Awards & 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: Prophylactic CarvedilolExperimental Treatment1 Intervention

Carvedilol 3.125 mg by mouth every 12 hours, titrated to a max dose of 25 mg by mouth every 12 hours, depending on blood pressure and heart rate, until completion of study.

Group II: No TherapyActive Control1 Intervention

Standard of care monitoring without prophylactic treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carvedilol

2011

Completed Phase 4

~1410

0 / 14Eligibility criteria met