JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

NANot yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2033

Conditions
Cardiovascular HealthBreast CancerBreast Cancer Early Stage Breast Cancer (Stage 1-3)Cardio-oncologyCirculatory and Respiratory HealthClinical and Translational Cardiovascular SciencesHealth Services and Systems - Healthcare Effectiveness &Amp; Outcomes
Interventions
DIAGNOSTIC_TEST

Intervention - Low Risk Group OR Intermediate Risk Group

"Participants will be randomized to judicious imaging (decreased imaging frequency based on HF risk category) or SOC (imaging every 3 months). Participants who do not have any HF risk factors will be categorized as low risk, while participants with at least one risk factor will be categorized as intermediate risk for HF.~Low Risk (zero risk factors): imaging before cycles 1 and 9 of HER2-TT (i.e., at baseline and near the halfway mark, corresponding to 2 fewer studies than SOC in Year 1), then after the end of HER2TT. This translates to imaging every 6 months for uninterrupted adjuvant HER2TT.~Intermediate Risk (any risk factors): imaging before cycles 1, 6, and 12 of HER2-TT (i.e., at baseline and near the 1/3 and 2/3 marks, corresponding to 1 fewer study than SOC in Year 1), then at end of HER2TT. This translates to imaging every 4 months for uninterrupted adjuvant HER2TT."

Trial Locations (1)

M5S 1B2

Women's College Hospital, Toronto

All Listed Sponsors
collaborator

University Health Network, Toronto

OTHER

lead

Women's College Hospital

OTHER