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

Ottawa Hospital Research Institute200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

200

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Southlake Regional Health Centre

Newmarket, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Outcomes

Primary Outcomes

LVEF Results

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 (%).

Time frame: Baseline to 1 year

Secondary Outcomes

Rates of Trastuzumab Delay and Discontinuation

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.

Time frame: 1 year

Referral to Cardiology

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.

Time frame: 1 year

Rate of Cardiac Events

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.

Time frame: 1 year