ACTIVE_NOT_RECRUITING

Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC) Trial

Quick Facts

Study Start:2019-08-21

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03879629

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Joerg Herrmann, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Phoenix, Arizona, 85054

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Washington University in St. Louis

Saint Louis, Missouri, 63110

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Joerg Herrmann, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-21

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2019-08-21

Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer