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

Running, not enrolling

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03983382

Run by

Memorial Sloan Kettering Cancer Center

People needed

190

Starts

2019-03-22

Expected to finish

2027-03-01

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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