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A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients | Clinical Trials | Clareo Health

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A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer

NCT03983382•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Age \>/= 18 years
•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

•Planned to receive an anthracycline-based regimen
•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)

Locations (8)

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

Key Dates

Start Date

March 22, 2019

Primary Completion Date

September 18, 2023

Completion Date

March 1, 2026

Last Updated

May 1, 2025

Enrollment

190

ACTUAL participants

Conditions

Breast Cancer

Interventions

Left Ventricular Ejection Fraction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

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