Using losartan to prevent heart failure from radiation in breast cancer patients
The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure
EARLY_PHASE1 · Massachusetts General Hospital · NCT05607017
This study is testing if the heart medication losartan can help prevent heart problems in breast cancer patients who are receiving radiation treatment.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05607017 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates whether losartan can reduce the risk of developing radiation-induced myocardial fibrosis in breast cancer patients undergoing radiation therapy. Participants will receive standard radiation treatment while taking losartan, an FDA-approved medication for hypertension and heart failure. The study will involve screening for eligibility, treatment administration, and follow-up evaluations over the course of one year. Approximately 10 patients will be enrolled to assess the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with non-metastatic left-sided breast cancer scheduled for radiation therapy.
Not a fit: Patients who are pregnant, breastfeeding, or unable to take oral medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help prevent heart failure in breast cancer patients receiving radiation therapy.
How similar studies have performed: While the use of losartan for this specific purpose is novel, similar studies have explored the cardioprotective effects of other agents in patients undergoing radiation therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Rachel Jimenez, MD — Massachusetts General Hospital
- Study coordinator: Rachel Jimenez, MD
- Email: rbjimenez@partners.org
- Phone: 617-726-8651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Myocardial Fibrosis, Radiation-Induced Fibrosis