A Study to Reduce Cardiomyopathy in Breast Cancer Patients Being Treated With Trastuzumab

Overview

About this study

The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • ≥18 years of age,
  • New diagnosis of HER2+ breast cancer,
  • Planned adjuvant (post-surgery) HER2-directed therapy,
  • And meeting either criteria #2 or #3 below for cardiac dysfunction risk. The latter is defined in the 2017 clinical practice guidelines on the prevention and monitoring of cardiac dysfunction in cancer patients by American Society of Clinical Oncology (ASCO).41 Three groups of cancer patients are deemed to be at risk of cardiac dysfunction and HF:
    1. Any patient receiving high-dose anthracycline (e.g., doxorubicin ≥ 250 mg/m2), high-dose radiotherapy (RT ≥ 30 Gy) where the heart is in the treatment field, or lower-dose anthracycline in combination with lower-dose RT, where the heart is in the treatment field,
    2. Treatment with lower-dose anthracycline or trastuzumab alone with any of the following risk factors:
      • ≥2 cardiovascular risk factors, including smoking, hypertension, diabetes, dyslipidemia, and obesity, age ≥60 years, compromised cardiac function (e.g. history of myocardial infarction, ≥ moderate valvular heart disease),
    3. Treatment with lower-dose anthracycline followed by trastuzumab (sequential therapy).

Exclusion Criteria:

  • History of HF of any class and type, or diagnosis of cardiomyopathy in the past,
  • LVEF <53% at screening,
  • Baseline use of cardvedilol, nebivolol or bisoprolol,
  • Current ACE inhibitor or ABR therapy for hypertension in the presence of diabetes and/or for chronic kidney disease/proteinuria,
  • Intolerance to beta-blocker,
  • Current anti-arrhythmic drug therapy,
  • History of bronchial asthma or related bronchospastic conditions,
  • Heart rate < 50 BPM at screening,
  • 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,
  • Severe hepatic dysfunction, as defined by NCI ODWG (total bilirubin >3x ULN, any AST elevation) or Child Pugh C class
  • Pregnancy,
  • Inability to provide informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Joerg Herrmann, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20438531

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