Status:
ACTIVE_NOT_RECRUITING
Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Toronto
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Brief Summary
Breast cancer is the most common cancer amongst Canadian women. 15-20% of early breast cancers have high levels of a protein called HER2 which is associated with worse survival. Treatment of these pat...
Eligibility Criteria
Inclusion
- Scheduled to undergo treatment with one of the following regimens: (a) 5-fluorouracil, epirubicin, cyclophosphamide, followed by docetaxel and trastuzumab, (b) adriamycin, cyclophosphamide, followed by docetaxel and trastuzumab, (c) adriamycin-cyclophosphamide with weekly paclitaxel and trastuzumab, or (d) dose dense adriamycin and cyclophosphamide followed by dose dense paclitaxel and trastuzumab
- Able to tolerate five \~60 minute CMR examinations over 15 months
- Able to give informed consent
Exclusion
- Life expectancy \< 12 months
- Participating in a clinical trial of a new cancer drug
- Having received previous anthracycline
- History of myocardial infarction or previous heart failure
- Current unstable angina, persistent atrial fibrillation or other irregular rhythm, or a history of more than mild regurgitant or stenotic valvular heart disease
- Severely reduced renal function (GFR ≤ 30 milliliters/minute)
- General MRI contraindications
- Baseline LVEF \<55% by echo
- echocardiography image quality inadequate for strain analysis
Key Trial Info
Start Date :
October 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02306538
Start Date
October 1 2013
End Date
January 1 2027
Last Update
February 14 2023
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2