Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis
Conditions
Keywords
Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis
Brief summary
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
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.
Interventions
DRUGLosartan
Taken Orally
RADIATIONRadiation Therapy
Photon Radiation Therapy
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extracellular Volume (ECV) of Myocardial Fibrosis | 6 months | The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum cardiac biomarker | 6 months | The secondary objective of this study is to compare pre- and post-Radiation Therapy changes in serum TGF-β levels |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRachel Jimenez, MD
Massachusetts General Hospital
Outcome results
None listed