Losartan in Prevention of Radiation-Induced Heart Failure

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607017
• Other study ID #: 22-457
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: Rachel Jimenez, MD
• Phone: 617-726-8651
• Email: rbjimenez[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Fibrosis
• Heart Failure
• Myocardial Fibrosis
• Radiation-Induced Fibrosis

Intervention

Drug:
• Losartan
Taken Orally

Radiation:
• Radiation Therapy
Photon Radiation Therapy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extracellular Volume (ECV) of Myocardial Fibrosis	The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI	6 months
Secondary	Serum cardiac biomarker	The secondary objective of this study is to compare pre- and post-Radiation Therapy changes in serum TGF-ß levels	6 months