Back to resultsAn 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)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
LVEF 3 month
LVEF 4 month
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring cardiac toxicities
Eligibility 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
Sites / Locations
- The Ottawa Hospital
- The Ottawa Hospital Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LVEF 3 month
LVEF 4 month
Arm Description
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Outcomes
Primary Outcome Measures
LVEF results
Changes in LVEF results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT02696707
First Posted
February 18, 2016
Last Updated
March 1, 2021
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02696707
Brief 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
Acronym
OTT 15-05
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 Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
cardiac toxicities
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LVEF 3 month
Arm Type
Active Comparator
Arm Description
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
Arm Title
LVEF 4 month
Arm Type
Active Comparator
Arm Description
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Intervention Type
Procedure
Intervention Name(s)
LVEF 3 month
Intervention Description
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
Intervention Type
Procedure
Intervention Name(s)
LVEF 4 month
Intervention Description
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Primary Outcome Measure Information:
Title
LVEF results
Description
Changes in LVEF results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy
Time Frame
at year one
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olexiy Aseyey, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2H 8L6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34940066
Citation
Dent S, Fergusson D, Aseyev O, Stober C, Pond G, Awan AA, McGee SF, Ng TL, Simos D, Vandermeer L, Saunders D, Hilton JF, Hutton B, Clemons M. A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer. Curr Oncol. 2021 Dec 3;28(6):5073-5083. doi: 10.3390/curroncol28060427.
Results Reference
derived
Learn more about this trial
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
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