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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)

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ClinicalTrials.gov Identifier: NCT02696707
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: LVEF 3 month Procedure: LVEF 4 month Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : June 2016
Actual Primary Completion Date : May 2020
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. LVEF results [ Time Frame: at year one ]
    Changes in LVEF results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696707


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K2H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Olexiy Aseyey, MD The Ottawa Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02696707    
Other Study ID Numbers: 20150777-01H
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ottawa Hospital Research Institute:
cardiac toxicities
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases