Plain English Summary
Background and study aims
Trastuzumab is a drug that targets oestrogen signalling and can be used to treat selected breast cancer patients. It has been shown to delay and prevent death from breast cancer. However, with more patients surviving breast cancer, it becomes more important to prevent side effects. Trastuzumab can lead to heart failure in up to a quarter of patients receiving this drug. In most cases this heart failure is reversible after trastuzumab treatment finishes. However, these patients have higher lifetime risk of heart problems such as chronic (long-lasting) heart failure, myocardial infarctions (heart attacks) or other forms of heart disease. Until now, the main way to prevent trastuzumab-associated heart failure is repeated screening using echocardiography (ultrasound scanning of the heart). It is possible that MRI scans of the heart might show the early signs of heart failure resulting from trastuzumab treatment long before symptoms occur. This study aims to compare heart MRI scans before, during and after trastuzumab therapy and to identify the MRI changes that best predict which patients will later develop trastuzumab-associated heart failure. Doing this we might be able to make trastuzumab therapy safer in the future.
Who can participate?
Adult patients with breast cancer who are expected to be treated with trastuzumab
What does the study involve?
All participants receive heart MRI scans before, during and after five treatments with trastuzumab. All participants receive treatment for their breast cancer as usual.
What are the possible benefits and risks of participating?
Participants might benefit from earlier detection of heart problems using MRI compared to ultrasound. During the MRI scan, participants receive a standard dose of contrast medium that in rare occasions can cause allergic reactions. However, there are no study-associated side effects that exceed those of a regular MRI scan.
Where is the study run from?
HELIOS Hospital Berlin-Buch (Germany)
When is the study starting and how long is it expected to run for?
June 2018 to December 2020
Who is funding the study?
The cost of this study will be funded by the research group itself through university-affiliated research grants. No external funding is needed.
Who is the main contact?
Dr Fabian Muehlberg
Fabian.muehlberg@helios-gesundheit.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fabian Muehlberg
ORCID ID
http://orcid.org/0000-0002-7981-5178
Contact details
HELIOS Hospital Berlin-Buch/Working group Cardiac MRI
Schwanebecker Chaussee 50
Berlin
13125
Germany
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HER2-CMR
Study information
Scientific title
Prediction of trastuzumab-associated cardiomyopathy using cardiovascular MRI
Acronym
HER2-CMR
Study hypothesis
Trastuzumab is known to be induced reversible and irreversibly congestive heart failure. We hypothesized that cardiac MRI is able to detect early changes in the myocardial structure after the first application of trastuzumab but long before clinical signs of heart failure occur. In detail, we hypothesized that myocardial T1 times change very early after start of trastuzumab.
Ethics approval
Charité University Medicine Berlin Ethics Board (Campus Mitte), 23/10/2018, ref: EA1/176/18
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Trastuzumab-associated cardiomyopathy
Intervention
Participants receive a maximum of four cardiac MRIs. One MRI before start of chemotherapy (which typically happens before start of trastuzumab), one MRI directly before start of trastuzumab, one MRI directly before the second administration of trastuzumab and one MRI after 5 cycles of trastuzumab.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Mean native myocardial T1 time measured using MRI (MOLLI sequences) at all time points (before start of chemotherapy, before the first dose of trastuzumab, before the second dose of trastuzumab and after 5 cycles of trastuzumab)
Secondary outcome measures
1. Left ventricular ejection fraction
2. Myocardial T2 time
3. Late gadolinium enhancement
4. Longitudinal strain
5. Circumferential strain
All secondary outcome measures are assessed using MRI at all time points (before start of chemotherapy, before the first dose of trastuzumab, before the second dose of trastuzumab and after 5 cycles of trastuzumab).
Overall trial start date
01/06/2018
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Mammary carcinoma
2. Planned trastuzumab therapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Any absolute contraindication for MRI
2. Chronic renal failure with GFR <30 ml/min/m2 at time of inclusion
Recruitment start date
30/11/2018
Recruitment end date
31/07/2020
Locations
Countries of recruitment
Germany
Trial participating centre
HELIOS Hospital Berlin-Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany
Funders
Funder type
University/education
Funder name
Working Group Cardiac MRI @ Charité University Medicine Berlin & HELIOS Hospital Berlin-Buch
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are intending to publish at least one research article in a high-ranking peer-reviewed journal, such as JCMR (impact factor 6.5)
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to reasons of data protection laws in Germany. However, upon request methodology and data set structure can be shared.
Intention to publish date
31/12/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list