Carvedilol for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerCarvedilol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a beta blocker called carvedilol can help protect the hearts of breast cancer patients taking trastuzumab-based HER2-directed therapy, either by starting it when significant heart function decline or early signs of heart injury are noted, or preventatively before beginning trastuzumab-based therapy.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 2 years

1 year
Cardiac function changes after completion of HER2-directed therapy
Rate of asymptomatic and symptomatic cardiac dysfunction
Rate of reversible cardiac function decline
2 years
Gene variants and risk of cardiotoxicity and response to therapy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Standard of Care
1 of 3
Pre-Emptive Strategy
1 of 3
Reactive Strategy
1 of 3

Active Control

Experimental Treatment

450 Total Participants · 3 Treatment Groups

Primary Treatment: Carvedilol · No Placebo Group · Phase 2

Pre-Emptive Strategy
Drug
Experimental Group · 1 Intervention: Carvedilol · Intervention Types: Drug
Reactive Strategy
Drug
Experimental Group · 1 Intervention: Carvedilol · Intervention Types: Drug
Standard of Care
Drug
ActiveComparator Group · 1 Intervention: Carvedilol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,918 Previous Clinical Trials
3,506,530 Total Patients Enrolled
83 Trials studying Breast Cancer
16,577 Patients Enrolled for Breast Cancer
Miami Heart Research InstituteUNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,403 Total Patients Enrolled
923 Trials studying Breast Cancer
1,535,329 Patients Enrolled for Breast Cancer
Joerg HerrmannPrincipal Investigator - Mayo Clinic
Mayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You have HER2+ breast cancer that will be treated with curative intent.