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Carvedilol for Preventing Heart Problems in HER2 Positive Breast Cancer

Phase 3

Recruiting

Led By Justin Floyd

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must be able to swallow tablets

Patients must not be currently taking or planning to take during study treatment specific medications: B2 agonists, Bosutinib, Ceritinib, Floctafenine, Methacholine, Pazopanib, Rivastigmine, Vincristine, Silodosin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 108 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial studies the effects of carvedilol on preventing heart problems in patients with HER2-positive breast cancer.

Who is the study for?

This trial is for adults with HER-2-positive metastatic breast cancer who are starting or continuing trastuzumab-based therapy. They must have normal heart function, blood pressure, and not be on certain heart medications. Pregnant or nursing individuals can't join, nor those with other recent cancers except some specific cases.

What is being tested?

The study tests if carvedilol can prevent heart damage in patients receiving cancer treatment for HER-2-positive metastatic breast cancer. It involves taking the beta-blocker carvedilol alongside standard chemotherapy to see if it reduces cardiac toxicity.

What are the potential side effects?

Carvedilol may cause dizziness, fatigue, low blood pressure, slower heart rate, and changes in blood sugar levels. As a beta-blocker used for high blood pressure and heart failure, its side effects are generally well understood.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow pills.

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I am not taking and do not plan to take certain medications during the study.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I do not require dialysis.

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My asthma is under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 108 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 108 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 108 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to the first identification of cardiac dysfunction

Secondary study objectives

Drug adherence

Incidence of adverse events associated with beta blocker treatment

Rate of death

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: Arm I (carvedilol)Experimental Treatment2 Interventions

Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol PO BID. Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (no intervention)Active Control1 Intervention

Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks.

Group III: Arm III (observation)Active Control2 Interventions

Patients undergo observation for up to 108 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carvedilol

2011

Completed Phase 4

~1410