NCT02696707

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	LVEF 3 month	cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
PROCEDURE	LVEF 4 month	cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-05-01
• Completion: 2020-07-01
• First posted: 2016-03-02
• Last updated: 2025-12-18
• Results posted: 2025-07-14

Locations

4 sites across 1 country: Canada