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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Southlake Regional Health Centre, Newmarket, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LVEF 3 month

Procedure

cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months

LVEF 4 month

Procedure

cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months

Primary outcomes

  1. 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 (%).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Acronym: OTT 15-05

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2016
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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