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

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT02696707
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 30, 2016
Status verified
Dec 2025
Primary completion
May 31, 2020
Completion
Jul 31, 2020

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: 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

Primary Outcome Measure

LVEF Results [ Time Frame: Baseline to 1 year ]

Related Studies