Could a common blood pressure drug prevent radiation scarring in breast cancer patients?
NCT ID NCT05637216
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether losartan, a drug already used for high blood pressure, can reduce scarring (fibrosis) caused by radiation therapy in breast cancer patients. 43 women who had breast surgery and need radiation will receive either losartan or a placebo. Researchers will measure breast and lung scarring using exams and CT scans, along with blood markers of inflammation and aging cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Losartan (a blood pressure drug)
- What this could lead to
- If it works, this could point toward a way to prevent or reduce scarring and stiffness in breast tissue and lungs after radiation therapy.
- What could go wrong
- This is a small, early-phase pilot study with only 43 participants. The drug is already approved for blood pressure, but its effect on radiation fibrosis is unproven, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 43 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Diagnosed with clinical or pathologic stage 0-IV invasive breast cancer to include ductal carcinoma in situ (Tis), primary tumor cannot be assessed (TX) and all other primary tumor stage categories (T1-T4) * Has been treated with breast conserving surgery or mastectomy with reconstruction * Is a candidate for unilateral post-surgery radiation therapy per National Comprehensive Cancer Network (NCCN) guidelines * Age ≥ 18 * Female * Laboratory values * Aspartate Aminotransferase (AST) ≤ 2.5 x Upper Limit Normal (ULN) * Alanine Aminotransferase (ALT) ≤ 2.5 x ULN * Creatine ≤ 1.5 x ULN * Estimated Glomerular Filtration Rate (eGFR) ≥ 60 Inclusion of Women and Minorities - Women of any race/ethnicity are eligible for this trial. Exclusion Criteria * Recurrent breast cancer and history of prior breast radiation therapy * Breast cancer requiring bilateral breast/chest wall radiation therapy * Undergoing concurrent chemotherapy treatment * Documented fall risk * Active known diagnosis of a connective tissue disorder, rheumatoid arthritis, or systemic lupus erythematosus (SLE) * Any known uncontrolled intercurrent illness including, but not limited to: * Hyperkalemia * Impaired renal function * Symptomatic congestive heart failure * Unstable angina pectoris * Kidney disease * Uncontrolled diabetes * Cystic fibrosis * Fibromyalgia based on American College of Rheumatology criteria * Concomitant use of: * Losartan * Other renin-angiotensin system (RAS) agent * Agents to increase serum potassium * Lithium * Aliskiren for diabetes * Having a known allergy to any active or inactive ingredient in Losartan * Unable to tolerate oral medication * Pregnant or breast-feeding or planning pregnancy for the year following radiation * A medical history of interstitial lung disease or evidence of interstitial lung disease * Patients with any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Clinical Investigator or his/her designee), constitutes a risk or contraindication for participation in the study or that could interfere with the study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the study * Individuals known to possess deoxyribonucleic acid (DNA) gene mutations including: * Ataxia-Telangiectasia Mutated (ATM) * Double-strand-break repair protein rad21 homolog (RAD21) * C-to-T single-nucleotide polymorphism (C-509T) in the Transforming growth factor β-1 gene
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vail Health Shaw Cancer Center
Edwards, Colorado, 81632, United States
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