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Carvedilol for Cardiomyopathy in Breast Cancer Patients (TACTIC Trial)

Phase 2
Recruiting
Led By Joerg Herrmann
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Planned HER2-directed therapy (any therapy targeting HER2 signaling including Trastuzumab +/- pertuzumab or trastuzumab-emtansine (T-DM1) Nerantinib and lapatinib will not be considered)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

TACTIC Trial 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.

Who is the study for?
This trial is for adults over 18 with a new or recurring HER2+ breast cancer, treated with curative intent and planned HER2-directed therapy. It's not for those with past heart failure/cardiomyopathy, low heart function at screening, certain blood pressure/heart rhythm issues, severe liver dysfunction, pregnancy, metastatic breast cancer or intolerance to beta-blockers.Check my eligibility
What is being tested?
The study tests if the beta-blocker carvedilol can protect the heart when given during trastuzumab-based HER2-directed therapy for breast cancer. Participants are randomly assigned to start carvedilol either after early signs of heart injury or preventatively before treatment. They may continue or stop taking it after completing trastuzumab therapy.See study design
What are the potential side effects?
Carvedilol may cause dizziness, fatigue, low blood pressure, slower heartbeat rate and other cardiovascular effects. Some people might experience digestive disturbances or breathing difficulties if they have a history of asthma.

TACTIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for a treatment targeting HER2, excluding Nerantinib and Lapatinib.
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I have a new or returning HER2+ breast cancer and plan to treat it to cure.

TACTIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of asymptomatic and symptomatic cardiac dysfunction
Rate of reversible cardiac function decline
Secondary outcome measures
Cardiac function changes after completion of HER2-directed therapy
Gene variants and risk of cardiotoxicity and response to therapy

TACTIC Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Reactive StrategyExperimental Treatment1 Intervention
Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated after documentation of subclinical cardiotoxicity, defined by an abnormal global longitudinal strain (GLS) or high-sensitive cardiac troponin (hsTnI) elevation and continued until end of therapy
Group II: Pre-Emptive StrategyExperimental Treatment1 Intervention
Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated one week before start of therapy and continued until end of therapy
Group III: Standard of CareActive Control1 Intervention
Carvedilol titrated to maximally tolerated doses (3.125 mg to 25 mg twice a day) initiated after documentation of a drop in LVEF by >10% to a value less than 53% and continued until end of therapy
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?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,035 Total Patients Enrolled
82 Trials studying Breast Cancer
13,596 Patients Enrolled for Breast Cancer
Miami Heart Research InstituteUNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,897 Total Patients Enrolled
938 Trials studying Breast Cancer
1,542,893 Patients Enrolled for Breast Cancer

Media Library

Carvedilol Clinical Trial Eligibility Overview. Trial Name: NCT03879629 — Phase 2
Breast Cancer Research Study Groups: Pre-Emptive Strategy, Reactive Strategy, Standard of Care
Breast Cancer Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT03879629 — Phase 2
Carvedilol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03879629 — Phase 2

Frequently Asked Questions

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

Has Carvedilol met all the necessary safety requirements for public consumption?

"Carvedilol's power rating sits at a 2. While there is some evidence backing its safety, none of the available data supports carvedilol's efficacy."

Answered by AI

Are there other similar test programs that have used Carvedilol before?

"At the moment, 29 different clinical trials are underway to research carvedilol. 7 of those live clinical trials are in Phase 3. Orlando, Florida hosts the majority of trials for this treatment, but there are 978 locations running studies for it in total."

Answered by AI

What are the common illnesses that Carvedilol is used to manage?

"Carvedilol's therapeutic benefits include reducing hypertension and treating heart failure, hypesthesia, and left ventricular dysfunction."

Answered by AI

How many test subjects are in this experiment?

"In order to have this study be feasible, 450 individuals who meet the pre-set inclusion criteria must enroll. Some of the places where these people can join the trial are Mayo Clinic in Phoenix, Arizona and Mayo Clinic in Rochester, Minnesota."

Answered by AI

Are researchers still looking for participants in this trial?

"The clinical trial is currently enrolling patients, with the most recent update on August 25th, 2022. The listing was first posted on August 21st, 2019."

Answered by AI
~207 spots leftby Feb 2028