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Breast NeoplasmsEMBRACE-MRINCT02306538

Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI

An observational study of Breast Neoplasms, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 patients with anthracyclines followed by trastuzumab (which targets HER2) improves survival. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Neoplasms
How many people
180 participants
Where
1 siteCanada
Study dates
Oct 2013to Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Women ≥18 years with stage I-III, HER2+ breast cancer

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • General MRI contraindications
  • Baseline LVEF <55% by echo
  • echocardiography image quality inadequate for strain analysis

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

Official title: Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI - The EMBRACE MRI Study

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 patients with anthracyclines followed by trastuzumab (which targets HER2) improves survival. Unfortunately, these medications together can cause heart muscle injury resulting in heart dysfunction or failure in about 14% and 3.6% of the patients, respectively. Once heart failure (HF) occurs, about 60% of patients will not live past 2 years. Studies have suggested that patients with heart injury caused by anthracyclines may be more likely to develop HF with addition of trastuzumab. Therefore tests to find early heart injury after anthracyclines may allow doctors to start heart protective medications with the hope of preventing HF. Also, animal and small patient studies have shown that an increase in the water levels of the heart muscle (edema) may be an early sign of heart injury from anthracyclines. Cardiac MRI is a unique technique that has been shown to detect edema in various heart diseases.

The investigators will test the theory that, in women receiving treatment for breast cancer, heart edema detected by MRI at the end of anthracyclines will identify patients who will later develop heart dysfunction. MRI studies with novel techniques will be done pre-therapy, after anthracyclines, during herceptin, and at end of all therapy. The investigators will compare patients with and without heart dysfunction to test if patients with heart dysfunction are more likely to have edema after anthracyclines. Ultimately the investigators hope to use cardiac MRI to identify high risk patients and study various heart protective medications to prevent HF. This will improve the personal health of cancer patients by allowing them to live free of heart disease after their cancer therapy. Ultimately at a population level this will allow doctors to provide care that can be uniquely designed for each patient based on their individual risk.

Read more

The first 136 patients enrolled are included in the first part of the study, named EMBRACE-MRI 1. Enrollment for this part of the study is complete.

The remaining 44 patients will be enrolled into EMBRACE-MRI 2, which includes slight differences in obtaining sequences in MRI imaging.

Keywords
edema, inflammation, scar, ejection fraction, volumes
Medical subject headings
Breast Neoplasms, Edema, Inflammation, Cicatrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The presence of myocardial edema stratified by the presence or absence of conventionally defined cardiotoxicity (this is a binary outcome).

    Myocardial edema is defined as an 8% increase in segmental T2 values measured in milliseconds in at least 2 myocardial segments at either of the 2 early time points. Cardiotoxicity is defined as Cardiac Magnetic Resonance Imaging (CMR) measured (1) ≥5% absolute reduction in Left Ventricular Ejection Fraction (LVEF) from baseline to an LVEF <55% with signs or symptoms of HF, OR (2) a ≥10% absolute reduction in LVEF from baseline to <55% without accompanying signs or symptoms at the time points when CMR is obtained OR (3) the same amount of reduction in LVEF as above, identified by echo at any time point (done every 3 months) and confirmed by CMR at that time.

    Measured: 2-15 months

Secondary outcomes (1)

  1. The presence of edema stratified by the presence or absence of any drop in LVEF ≥5% by CMR by end of therapy (this is a binary outcome).

    Please see definition for edema above

    Measured: 2-15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionAug 2024 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02306538
Sponsor's protocol ID
13-6543C
Acronym
EMBRACE-MRI
Status last verified
May 2022
First submitted
11 Nov 2014
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Huang F, Rankin K, Sooriyakanthan M, Signorile M, Steve Fan CP, Thampinathan B, Marwick TH, Osataphan N, Yu C, Koch CA, Amir E, Hanneman K, Abdel-Qadir H, Wintersperger BJ, Thavendiranathan P. Phenotypes of Myocardial Dysfunction on Serial Echocardiography and CMR in Women With Early-Stage Breast Cancer. JACC Cardiovasc Imaging. 2025 May;18(5):540-553. doi: 10.1016/j.jcmg.2024.12.010. Epub 2025 Mar 19.

    PubMed 40117396

  • Calvillo-Arguelles O, Thampinathan B, Somerset E, Shalmon T, Amir E, Steve Fan CP, Moon S, Abdel-Qadir H, Thevakumaran Y, Day J, Woo A, Wintersperger BJ, Marwick TH, Thavendiranathan P. Diagnostic and Prognostic Value of Myocardial Work Indices for Identification of Cancer Therapy-Related Cardiotoxicity. JACC Cardiovasc Imaging. 2022 Aug;15(8):1361-1376. doi: 10.1016/j.jcmg.2022.02.027. Epub 2022 May 11.

    PubMed 35926895

  • Esmaeilzadeh M, Urzua Fresno CM, Somerset E, Shalmon T, Amir E, Fan CS, Brezden-Masley C, Thampinathan B, Thevakumaran Y, Yared K, Koch CA, Abdel-Qadir H, Woo A, Yip P, Marwick TH, Chan R, Wintersperger BJ, Thavendiranathan P. A Combined Echocardiography Approach for the Diagnosis of Cancer Therapy-Related Cardiac Dysfunction in Women With Early-Stage Breast Cancer. JAMA Cardiol. 2022 Mar 1;7(3):330-340. doi: 10.1001/jamacardio.2021.5881.

    PubMed 35138325

  • Houbois CP, Nolan M, Somerset E, Shalmon T, Esmaeilzadeh M, Lamacie MM, Amir E, Brezden-Masley C, Koch CA, Thevakumaran Y, Yan AT, Marwick TH, Wintersperger BJ, Thavendiranathan P. Serial Cardiovascular Magnetic Resonance Strain Measurements to Identify Cardiotoxicity in Breast Cancer: Comparison With Echocardiography. JACC Cardiovasc Imaging. 2021 May;14(5):962-974. doi: 10.1016/j.jcmg.2020.09.039. Epub 2020 Nov 25.

    PubMed 33248962

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The presence of myocardial edema stratified by the presence or absence of conventionally defined cardiotoxicity (this is a binary outcome). (time frame: 2-15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02306538, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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