Condition category
Injury, Occupational Diseases, Poisoning
Date applied
14/11/2018
Date assigned
23/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

Working Group Cardiac MRI @ Charité University Medicine Berlin & HELIOS Hospital Berlin-Buch

Sponsor details

Lindenberger Weg 80
Berlin
13125
Germany

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

23/11/2018: Internal review.