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 (OTT 15-05)

December 5, 2025 updated by: Ottawa Hospital Research Institute

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Ottawa, Ontario, Canada, K2H 8L6
        • The Ottawa Hospital Cancer Centre
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LVEF 3 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
Procedure: LVEF 3 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
Active Comparator: LVEF 4 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Procedure: LVEF 4 month
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LVEF Results
Time Frame: Baseline to 1 year
Changes in Left Ventricular Ejection Fraction (LVEF) results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy. LVEF is measured as a percentage. The outcome is a change in LVEF percentage (%).
Baseline to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Trastuzumab Delay and Discontinuation
Time Frame: 1 year
The number of participants who had a delay and/or discontinuation in trastuzumab treatment. Data was collected from physicians following clinic visits and from patient electronic medical records.
1 year
Referral to Cardiology
Time Frame: 1 year
The number of participants who were referred to cardiology. Data was collected from physicians following clinic visits, and from the patient's electronic medical record.
1 year
Rate of Cardiac Events
Time Frame: 1 year
The number of participants who experienced a decrease in ejection fraction (EF), congestive heart failure, or other cardiac events within the 1 year of study. Examples of other cardiac events include change in blood pressure, chest pain/shortness of breath, or irregular heartbeat. Data was collected/reported from physicians following clinic appointments, and from the patient's electronic medical record.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Olexiy Aseyey, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimated)

March 2, 2016

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150777-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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