Frequency of Cardiac Monitoring in Patients Treated with HER2-Directed Therapies for Breast Cancer

Not Applicable

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12624000148572
• Lead Sponsor: Monash Health Department of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-16
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

•Capable of providing written informed consent and willing to adhere to all protocol requirements
•Histologically confirmed HER2-positive breast cancer, as confirmed on immunohistochemistry (IHC) or fluorescence in situ hybridisation; Participants with IHC 1+ or 2+ results, also known as HER2-low cancer, are allowed to participate if they are planned for treatment with HER2-directed therapies
•Planned for or commenced treatment with HER2-directed therapy for less than 3 months, which include monotherapy or combination therapy with any of the following agents - Trastuzumab, Pertuzumab, Trastuzumab emtansine, Trastuzumab deruxtecan, Neratinib, Lapatinib

Exclusion Criteria

•Unable to provide written informed consent
•Unable or unwilling to adhere to all protocol requirements
•Commenced current treatment with HER2-directed therapy for 3 months or longer
•History of left ventricular dysfunction or heart failure with reduced ejection fraction, defined as left ventricular ejection fraction of <50% (this includes patients with left ventricular dysfunction identified on baseline screening echocardiogram or previous left ventricular dysfunction that recovered with cardioprotective medications)
•History of left ventricular dysfunction during previous treatment with HER2-directed therapies
•History of severe valvular heart disease
•Poor imaging quality on baseline screening echocardiogram limiting interpretation of baseline and potentially future echocardiogram results
•Severe uncontrolled tachyarrhythmia
•History of ventricular tachycardia or ventricular fibrillation
•History of permanent pacemaker or implantable cardiac defibrillator implantation
•Prognostic factors associated with an expected survival less than 12 months as per treating clinician discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified