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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy and Losartan | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Taken Orally |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
->18 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Jimenez, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000087525 | Radiation Fibrosis Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Radiation Therapy | Radiation | Photon Radiation Therapy |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D013812 | Therapeutics |