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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
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to the first identification of cardiac dysfunction
Secondary outcome measures
Drug adherence
Incidence of adverse events associated with beta blocker treatment
Rate of death
+2 moreTrial 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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,584 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,444 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
264,331 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping ability must be at least 50% as measured by a special heart ultrasound within 28 days before joining the study.Your liver enzyme levels are within five times the normal range.I can swallow pills.I have no cancer history except for certain treated cancers or those I've been free from for 5 years.You need to have had an electrocardiogram within the last 28 days to check your heart's electrical activity.I have metastatic breast cancer and am on or starting a trastuzumab-based treatment without anthracyclines.I am not taking and do not plan to take certain medications during the study.I can take care of myself and am up and about more than 50% of my waking hours.Your bilirubin level in the blood is not more than three times the normal limit.I do not require dialysis.My asthma is under control.I haven't used beta blockers, ARBs, or ACE inhibitors in the last 21 days.I am at high risk for heart issues due to previous treatments or health conditions.I had a full physical exam and medical history review within the last 28 days.My heart's pumping ability is confirmed to be good by a special heart test.Your blood pressure must be at least 80 mm Hg before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (no intervention)
- Group 2: Arm I (carvedilol)
- Group 3: Arm III (observation)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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