A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients
NCT ID: NCT03983382
Last Updated: 2025-05-01
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
190 participants
OBSERVATIONAL
2019-03-22
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HER2-Positive Breast Cancer
Left Ventricular Ejection Fraction
LVEF assessment at baseline, 6 months, and 12 months
Interventions
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Left Ventricular Ejection Fraction
LVEF assessment at baseline, 6 months, and 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV)
* Pathologically confirmed HER2-positive breast cancer
* Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months.
* Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal)
* William and able to comply with the requirements of the protocol
Exclusion Criteria
* Prior history of treatment with anthracycline chemotherapy
* History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator)
* Uncontrolled hypertension, defined as systolic blood pressure \>/= 160 mmHg and/or diastolic blood pressure \>/= 90 mmHg (as determined by the investigator)
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anthony Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only)
Hartford, Connecticut, United States
Memorial Sloan Kettering Cancer Center @ BaskingRidge (Consent and follow-up only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent and Follow-up)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent and Follow-up)
Rockville Centre, New York, United States
Countries
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References
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Yu AF, Dang CT, Jorgensen J, Moskowitz CS, DeFusco P, Oligino E, Oeffinger KC, Liu JE, Steingart RM. Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy. Cardiooncology. 2023 Mar 9;9(1):13. doi: 10.1186/s40959-023-00163-4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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19-045
Identifier Type: -
Identifier Source: org_study_id
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