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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
Study 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
13,708 Previous Clinical Trials
40,931,912 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,444 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
263,803 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
Media Library
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 I (carvedilol)
- Group 2: Arm II (no intervention)
- Group 3: Arm III (observation)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Laboratory Biomarker Analysis carry any risks for patients?
"There is some evidence of efficacy and multiple rounds of data supporting safety, meaning that Laboratory Biomarker Analysis scores a 3 on our team's 1-3 scale."
Answered by AI
Are there any patients who have yet to enroll in this clinical trial?
"That is accurate. According to the information available on clinicaltrials.gov, this study was first advertised on September 15th, 2017 and is still recruiting patients. They are looking for 817 individuals total, across 100 different centres."
Answered by AI
What can researchers learn from Laboratory Biomarker Analysis studies?
"Currently, there are 29 different ongoing trials that involve laboratory biomarker analysis. Out of these, 7 are in phase 3. Most of the clinical trials related to this topic are based in Orlando, Florida; however, there are 978 locations around the world conducting similar research."
Answered by AI
What does Laboratory Biomarker Analysis test for?
"Biomarker analysis can be used in laboratory settings to treat hypertensive disease, heart failure, and hypesthesia."
Answered by AI
In how many different places is this trial taking place?
"There are over 100 hospitals and medical centres around the country participating in this clinical trial, such as University of Kansas Cancer Center-Overland Park, University of Kansas Cancer Center at North Kansas City Hospital, Woman's Hospital, and many others."
Answered by AI
How many people are taking part in this experiment at most?
"Yes, as indicated on clinicaltrials.gov, this trial is open for recruitment. This particular study was posted on September 15th, 2017 and updated November 9th of this year. They are looking to enroll 817 patients from 100 different sites."
Answered by AI
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