TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol

Description

Breast cancer patients undergoing trastuzumab-based HER2-directed therapy are at risk of heart function decline or heart failure symptoms, but it is unknown if, when, and for how long cardiovascular protective strategies, e.g. with a beta-blocker, could help. This study randomly assigns those taking curative-intent trastuzumab-based HER2-directed therapy to the beta-blocker carvedilol-either when significant heart function decline or subtle early signs of heart injury (either by elevation of a cardiac blood biomarker, i.e. cardiac troponin, or by an abnormal heart ultrasound marker, i.e. global longitudinal strain) are noted, or preventatively before beginning trastuzumab-based HER2-directed therapy. This study will further randomly assign those patients on carvedilol to either discontinuation at the end of trastuzumab-based HER2-directed therapy or continuation for another year, providing much needed clinical trial data on what the best strategy ("tactic") for those at risk of cardiotoxicity with trastuzumab-based HER2-directed therapy is.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

Breast cancer patients undergoing trastuzumab-based HER2-directed therapy are at risk of heart function decline or heart failure symptoms, but it is unknown if, when, and for how long cardiovascular protective strategies, e.g. with a beta-blocker, could help. This study randomly assigns those taking curative-intent trastuzumab-based HER2-directed therapy to the beta-blocker carvedilol-either when significant heart function decline or subtle early signs of heart injury (either by elevation of a cardiac blood biomarker, i.e. cardiac troponin, or by an abnormal heart ultrasound marker, i.e. global longitudinal strain) are noted, or preventatively before beginning trastuzumab-based HER2-directed therapy. This study will further randomly assign those patients on carvedilol to either discontinuation at the end of trastuzumab-based HER2-directed therapy or continuation for another year, providing much needed clinical trial data on what the best strategy ("tactic") for those at risk of cardiotoxicity with trastuzumab-based HER2-directed therapy is.

TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC) Trial

TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic, Phoenix, Arizona, United States, 85054

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63110

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥18 years of age,
  • * new or locally recurrent diagnosis of HER2+ breast cancer that will be treated with curative intent
  • * planned HER2-directed (any therapy targeting HER2 signaling including Trastuzumab +/- pertuzumab or trastuzumab-emtansine (T-DM1) Nerantinib and lapatinib will not be considered. "HER2-directed therapy" or "anti-HER-2".
  • * history of HF of any class and type, or diagnosis of cardiomyopathy in the past,
  • * LVEF \<50% at screening,
  • * intolerance to beta-blocker,
  • * baseline use of any beta-blocker for coronary artery disease including myocardial infarction
  • * current ACE inhibitor or ARB therapy for hypertension in the presence of diabetes and/or for chronic kidney disease/proteinuria,
  • * on active therapy with amiodarone, sotalol, or any other antiarrhythmic
  • * Diagnosis of asthma with current daily use of anti-asthmatic therapy
  • * heart rate \< 50 BPM at screening (average of 3 most recent readings)
  • * history of or current sick sinus syndrome,
  • * AV block grade II or higher (unless patient has a permanent pacemaker) at screening,
  • * systolic blood pressure \< 90 mmHg at screening (average of 3 most recent readings)
  • * severe hepatic dysfunction, as defined by NCI ODWG (total bilirubin \>3x ULN, any AST elevation) or Child Pugh C class
  • * pregnancy
  • * Metastatic breast cancer (distant metastases)
  • * Active systemic treatment for non-breast cancer

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Joerg Herrmann, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2029-02-28