Losartan in Prevention of Radiation-Induced Heart Failure

Study Overview
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Brief Summary
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This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer. The interventions involved in this study are: Losartan Radiation Therapy (standard of care)

Detailed Description
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This is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy. Losartan is an U.S. Food and Drug Administration (FDA) approved drug used to treat hypertension (high blood pressure) and heart failure. The U.S. Food and Drug Administration (FDA) has not approved losartan for use in the treatment of breast cancer. The FDA has approved radiation therapy as a treatment option for breast cancer. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. It is expected participants will be on the study for 1 year. It is expected that about 10 people will take part in this research study.

Official Title
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The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure

Conditions
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Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis

Intervention / Treatment
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* Drug: Losartan
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ->18 years of age Non-metastatic Breast Cancer patients who are scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs) Prior chemotherapy is permitted Patients must have Left-sided Breast Cancer Ability to understand and the willingness to sign a written informed consent document No contraindication to MRI Exclusion Criteria: Person who is pregnant or breastfeeding. Patient unable to swallow oral medication. Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity Patients already receiving ACE/ARBs. Patients with a history of allergic reactions to Losartan biosimilars.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation Therapy and Losartan<br>Participants will receive radiation therapy 5x weekly over 1-6 weeks. Participants will receive Losartan 1x daily during radiation therapy and for up to 6 months afterward then be followed for 1 year | Drug: Losartan<br>* Taken Orally<br>* Other names: Losartan Potassium;Radiation: Radiation Therapy<br>* Photon Radiation Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracellular Volume (ECV) of Myocardial Fibrosis | The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cardiac biomarker | The secondary objective of this study is to compare pre- and post-Radiation Therapy changes in serum TGF-β levels | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis