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Carvedilol for Heart Protection in Breast Cancer Patients

Phase 2
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a history of HTN, hyperlipidemia, diabetes, mild CAD, mild valvular disease are permitted
Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is studying a new way to prevent heart problems in breast cancer patients who are at risk for developing them from their chemotherapy.

Who is the study for?
This trial is for women over 18 with early-stage HER2-positive breast cancer (Stages I-III) who are about to start treatment with specific chemotherapies known to affect the heart. They must have normal heart function and agree to use contraception. Excluded are those with severe pre-existing heart conditions, certain other health issues like severe asthma or liver dysfunction, pregnant/breastfeeding women, and anyone previously on beta-blockers.Check my eligibility
What is being tested?
The study tests whether Carvedilol, a beta-blocker medication, can prevent or delay heart damage in patients receiving chemotherapy that's tough on the heart. Patients' hearts will be monitored using advanced imaging techniques to detect early signs of strain or damage during their cancer treatment.See study design
What are the potential side effects?
Carvedilol may cause dizziness, fatigue, low blood pressure, slower heartbeat rate and sometimes symptoms like difficulty breathing if you have asthma. It's important for patients not already experiencing significant cardiac issues as it could worsen them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of high blood pressure, high cholesterol, diabetes, or mild heart issues.
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I am scheduled for treatment with anthracycline, trastuzumab, or pertuzumab.
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My pathology report includes HER2, estrogen, and progesterone status.
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I am taking heart medications other than beta-blockers or ACE inhibitors.
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I have no heart symptoms or only get short of breath after walking two blocks.
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I am over 18 and have early stage (I-III) breast cancer with high HER2.
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My heart's pumping ability is normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Global Longitudinal Strain
Secondary outcome measures
Number of cancer treatments

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic CarvedilolExperimental Treatment1 Intervention
Carvedilol 3.125 mg by mouth every 12 hours, titrated to a max dose of 25 mg by mouth every 12 hours, depending on blood pressure and heart rate, until completion of study.
Group II: No TherapyActive Control1 Intervention
Standard of care monitoring without prophylactic treatment.
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?

Northwestern UniversityLead Sponsor
1,576 Previous Clinical Trials
911,788 Total Patients Enrolled
39 Trials studying Breast Cancer
12,475 Patients Enrolled for Breast Cancer

Media Library

Carvedilol Clinical Trial Eligibility Overview. Trial Name: NCT02993198 — Phase 2
Breast Cancer Research Study Groups: Prophylactic Carvedilol, No Therapy
Breast Cancer Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT02993198 — Phase 2
Carvedilol 2023 Treatment Timeline for Medical Study. Trial Name: NCT02993198 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this research endeavor?

"This trial has closed its recruitment period and is no longer actively searching for patients. The post was initially published on April 1st 2015, with the last update made on April 14th 2022. However, there are still 2292 clinical trials recruiting participants who have cardiovascular abnormalities and 28 studies that accept Carvedilol users as volunteers."

Answered by AI

Is this investigation presently seeking additional participants?

"Unfortunately, this research trial is not presently taking on new participants. The study was initially posted in April 2015 and has since been updated as recently as April 2022. However, if you are looking for a different clinical trial that may be suitable to your needs, there are currently 2292 studies related to cardivascular illnesses recruiting patients and 28 trials associated with Carvedilol seeking enrolment."

Answered by AI

Could you provide information on prior research utilizing Carvedilol?

"Presently, there are 28 Carvedilol studies in progress with 7 entering Phase 3. Although Orlando, Florida is the epicentre of research for this drug, 976 clinical sites worldwide have launched trials focused on it."

Answered by AI

Has Carvedilol been cleared by the Food and Drug Administration?

"Based on the available data, Carvedilol was rated 2 on our safety scale. This is due to this being a Phase 2 trial and thus, while there is evidence of its security, no information exists regarding efficacy."

Answered by AI

What is Carvedilol's customary application?

"Carvedilol is a therapeutic agent that can be prescribed to address hypertensive disease and other conditions such as heart failure, hypesthesia, ventricular dysfunction, left."

Answered by AI
~9 spots leftby Dec 2024