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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: LVEF 3 month; Procedure: LVEF 4 month

• Registration Number: NCT02696707
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Study Start: 2016-06
• Primary Completion: 2020-05
• Study Completion: 2020-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Histologically confirmed early stage HER2-positive breast cancer
• Planned trastuzumab therapy for early stage breast cancer
• ≥18 years of age
• Able to provide verbal consent
• Normal LVEF (>53%) before trastuzumab therapy

Exclusion Criteria

• Contraindication to transthoracic echocardiography or MUGA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LVEF 3 month	LVEF 3 month	cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
LVEF 4 month	LVEF 4 month	cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months

Primary Outcome Measures

Name	Time	Method
LVEF results	at year one	Changes in LVEF results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy

Trial Locations

Locations (2)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada