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

NCT02306538 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2023-02-14

No results posted yet for this study

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. 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.

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.

Conditions

  • Breast Neoplasms

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Toronto

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Paaladinesh Thavendiranathan, MD · University Health Network, Toronto

  • Bernd Wintersperger, MD · University Health Network, Toronto

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2024-08-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306538 on ClinicalTrials.gov