An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
NCT ID: NCT02696707
Last Updated: 2025-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2016-06-30
2020-07-31
Brief Summary
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At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment.
At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as standard of care.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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LVEF 3 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
LVEF 3 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
LVEF 4 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
LVEF 4 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Interventions
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LVEF 3 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
LVEF 4 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Eligibility Criteria
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Inclusion Criteria
* Planned trastuzumab therapy for early stage breast cancer
* ≥18 years of age
* Able to provide verbal consent
* Normal LVEF (\>53%) before trastuzumab therapy
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Olexiy Aseyey, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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Southlake Regional Health Centre
Newmarket, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Countries
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References
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Dent S, Fergusson D, Aseyev O, Stober C, Pond G, Awan AA, McGee SF, Ng TL, Simos D, Vandermeer L, Saunders D, Hilton JF, Hutton B, Clemons M. A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer. Curr Oncol. 2021 Dec 3;28(6):5073-5083. doi: 10.3390/curroncol28060427.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Rethinking Clinical Trials (REaCT) Website
Other Identifiers
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20150777-01H
Identifier Type: -
Identifier Source: org_study_id