A Study to Compare Conventional Heart Echo Measurements with Newer 2 and 3 Dimensional Measurements of Mechanical Heart Strain after Trastuzumab Infusion

Overview

  • Study type

    Interventional
  • 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.
  • Site IRB
    • Rochester, Minnesota: 15-008290
    Sponsor Protocol Number: 15-008290

About this study

The purpose of this study is to compare conventional assessment of systolic ventricular function on a 2D heart echo with an assessment of more immediate changes in heart mechanics using 2D and 3D measurements of deformation and strain in patients undergoing infusion of Trastuzumab for breast cancer.

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

  • Histological diagnosis of breast cancer and undergoing trastuzumab treatment
    • Her2 gene amplification (2+, 3+) by immunohistochemical analysis (IHC) or fluorescence in situ hybridization (FISH)
    • Stage I-II-III-IV

Exclusion Criteria 

  • Inadequate image quality
  • Irregular R-R Interval
  • Age <18 years
  • Previous cardiovascular disease (coronary artery disease, congestive heart failure, cardiomyopathy)
  • Moderate or severe valvular stenosis or regurgitation
  • Uncontrolled hypertension
  • Moderate to severe pericardial effusion or pericardial metastasis
  • CNS metastasis
  • Previous trastuzumab treatment

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hector Villarraga, M.D.

Open for enrollment

Contact information:

Giulia Bruno M.D.

(507)538-1064

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CLS-20257221

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