← Back to Search

Carvedilol for Preventing Heart Problems in HER2 Positive Breast Cancer

Maywood, IL
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
No Placebo-Only Group
Pivotal Trial

Summary

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

See full description
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 below
Select...
I can swallow pills.
 show original
Select...
I am not taking and do not plan to take certain medications during the study.
 show original
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
 show original
Select...
I do not require dialysis.
 show original
Select...
My asthma is under control.
 show original

Timeline

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

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.

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
2019
Completed Phase 4
~1450

Find a Location

Closest Location:Overlook Hospital· Summit, NJ· 6 miles
Image of Overlook Hospital in Summit, United States.Image of Overlook Hospital in Summit, United States.Image of Overlook Hospital in Summit, United States.

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,148,616 Total Patients Enrolled
18 Trials studying Cardiotoxicity
3,866 Patients Enrolled for Cardiotoxicity
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
259,194 Total Patients Enrolled
1 Trials studying Cardiotoxicity
180 Patients Enrolled for Cardiotoxicity
SWOG Cancer Research NetworkLead Sponsor
402 Previous Clinical Trials
265,858 Total Patients Enrolled
1 Trials studying Cardiotoxicity
180 Patients Enrolled for Cardiotoxicity
Justin FloydPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Carvedilol Clinical Trial Eligibility Overview. Trial Name: NCT03418961 — Phase 3
Cardiotoxicity Research Study Groups: Arm II (no intervention), Arm I (carvedilol), Arm III (observation)
Cardiotoxicity Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT03418961 — Phase 3
Carvedilol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03418961 — Phase 3
~319 spots leftby Jan 2030