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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-006090
    • Scottsdale/Phoenix, Arizona: 18-006090
    • Jacksonville, Florida: 18-006090
    NCT ID: NCT03879629
    Sponsor Protocol Number: 18-006090

About this study

The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.

 

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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.

See eligibility criteria

Inclusion Criteria:

  • ≥ 18 years of age.
  • New or locally recurrent diagnosis of HER2+ breast cancer that will be treated with curative intent.
  • Planned HER2-directed therapy (any therapy targeting HER2 signaling including trastuzumab +/- pertuzumab or trastuzumab-emtansine (T-DM1)). Neratinib and lapatinib will not be considered “Her2-directed therapy” or “anti-HER2” for the purpose of this study.

Exclusion Criteria:

  • Metastatic breast cancer (distant metastases).
  • Active systemic treatment for non-breast cancer.
  • 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 history of bronchial asthma or related  bronchospastic conditions, 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 with any AST elevation) or Child Pugh C class.
  • Pregnancy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joerg Herrmann, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Joerg Herrmann, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Joerg Herrmann, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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-20469677

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