Laboratory Biomarker Analysis for Cardiotoxicity

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cardiotoxicity+6 More
Laboratory Biomarker Analysis - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Cardiotoxicity
  • Malignant neoplasm of breast
  • Breast
  • ERBB2 gene
  • Brain

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 108 weeks

Up to 108 weeks
Drug adherence
Incidence of adverse events associated with beta blocker treatment
Rate of death
Rate of first interruption of trastuzumab
Time to first occurrence of cardiac event
Time to the first identification of cardiac dysfunction

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Arm III (observation)
1 of 3
Arm II (no intervention)
1 of 3
Arm I (carvedilol)
1 of 3
Active Control
Experimental Treatment

817 Total Participants · 3 Treatment Groups

Primary Treatment: Laboratory Biomarker Analysis · No Placebo Group · Phase 3

Arm I (carvedilol)Experimental Group · 2 Interventions: Laboratory Biomarker Analysis, Carvedilol · Intervention Types: Other, Drug
Arm III (observation)ActiveComparator Group · 2 Interventions: Laboratory Biomarker Analysis, Patient Observation · Intervention Types: Other, Other
Arm II (no intervention)
Other
ActiveComparator Group · 1 Intervention: Laboratory Biomarker Analysis · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 108 weeks

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
382 Previous Clinical Trials
258,897 Total Patients Enrolled
1 Trials studying Cardiotoxicity
180 Patients Enrolled for Cardiotoxicity
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,296,821 Total Patients Enrolled
18 Trials studying Cardiotoxicity
3,166 Patients Enrolled for Cardiotoxicity
Justin FloydPrincipal InvestigatorSouthwest Oncology Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had previous anthracycline exposure.
You have completed the registration form.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.