At a glance
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An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
In Brief
A Phase 4 clinical trial evaluating LVEF 3 month and LVEF 4 month for Breast Cancer. Completed, enrolled 200 participants across 4 sites.
Detailed Summary
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%). At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment. At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as standard of care.
Study Details
Timeline
Interventions
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months