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

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Left Ventricular Ejection Fraction

• Registration Number: NCT03983382
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-22
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-12
• Primary Completion: 2023-09-18
• Status Verified: 2024-07
• Results First Submitted: 2024-08-01
• Results First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Results First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 190

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HER2-Positive Breast Cancer	Left Ventricular Ejection Fraction	-

Primary Outcome Measures

Name	Time	Method
Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.	12 months from baseline

Trial Locations

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 Cancer Center @ Commack (Consent and Follow up); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Consent and follow-up only); 🇺🇸 Montvale, New Jersey, 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