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Losartan for Radiation-Induced Heart Failure in Breast Cancer

Phase < 1

Recruiting

Led By Rachel Jimenez, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non-metastatic Breast Cancer patients scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)

Patients must have Left-sided Breast Cancer

Must not have

Patient unable to swallow oral medication

Patients already receiving ACE/ARBs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at if losartan can reduce risk of radiation-induced heart failure in breast cancer patients receiving radiation therapy.

Who is the study for?

This trial is for adults over 18 with non-metastatic left-sided breast cancer scheduled for radiation therapy, including internal mammary lymph nodes. They must be able to consent and have no MRI contraindications. Excluded are pregnant or breastfeeding individuals, those allergic to Losartan biosimilars, unable to swallow pills, or already on ACE/ARBs.

What is being tested?

The study tests if Losartan can prevent heart failure caused by radiation in breast cancer treatment. Participants will receive standard radiation therapy and either Losartan or a placebo to compare outcomes.

What are the potential side effects?

Losartan may cause dizziness due to low blood pressure, kidney function changes, high potassium levels, and rare allergic reactions. Radiation therapy might lead to skin irritation at the site of treatment and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have breast cancer that hasn't spread and will receive radiation therapy to the left side, including lymph nodes.

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My breast cancer is in the left breast.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills.

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I am currently taking ACE inhibitors or ARBs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Extracellular Volume (ECV) of Myocardial Fibrosis

Secondary study objectives

Serum cardiac biomarker

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation Therapy and LosartanExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losartan

2003

Completed Phase 4

~3000

Radiation Therapy

2017

Completed Phase 3

~7250