Status:
COMPLETED
CARdiac Function Evaluation in Breast Cancer Patients
Lead Sponsor:
Swansea University
Collaborating Sponsors:
Abertawe Bro Morgannwg University Health Board
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Brief Summary
This study will investigate the influence of systemic adjuvant/neoadjuvant therapy (SAT: chemotherapy +/- anti-HER2 antibodies (trastuzumab +/- pertuzumab) on heart function/rhythm and cardio-respirat...
Detailed Description
This study will focus on the following: 1. Cardiac function assessment: The conventional method for assessing heart function (in terms of 'ejection fraction') in patients being treated for cancer use...
Eligibility Criteria
Inclusion
- Eligible participants will be women aged 18 years or over with the following characteristics:
- Early invasive breast cancer (stage I-III)
- Due to start adjuvant or neoadjuvant therapy including either anthracycline-based chemotherapy, or chemotherapy + trastuzumab +/- pertuzumab
- WHO performance status \<=2
- Absence of major cardiovascular or chronic respiratory problems, or other conditions that in the opinion of the clinician would contraindicate the use of physical exercise assessments
- Absence of contraindications for MRI scans, as listed in Paragraph 3.3. Patients unsuitable or unwilling to undergo MRI scans will be eligible for the study only if they are planned to receive trastuzumab, since this will include LVEF monitoring with MUGA scans or echocardiograms as part of routine care
- Provision of signed informed consent.
Exclusion
- Presence of major cardiovascular or chronic respiratory problems, or other conditions that in the opinion of the clinician would contraindicate the use of treadmill exercise assessments
- Presence of contraindications for MRI scans:
- Internal electronic devices such as neurostimulators or defibrillators
- Replacement heart valve
- Cardiac pacemaker
- Intracranial vessel clips
- Internal ear implant
- Claustrophobia
- Pregnancy.
- MRI scans will be requested by a clinician after the exclusion of the above contraindications. Patients unsuitable or unwilling to undergo MRI scans will be eligible for the study only if they are planned to receive trastuzumab, since this includes LVEF monitoring with MUGA scans or echocardiograms as part of routine care.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03266809
Start Date
August 1 2017
End Date
April 1 2020
Last Update
December 1 2022
Active Locations (1)
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1
Singleton Hospital
Swansea, Wales, United Kingdom, SA2 8PP