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Could a common blood pressure drug prevent radiation scarring in breast cancer patients?

NCT ID NCT05637216

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Aug 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.

breast cancer breast neoplasm Camurati-Engelmann Syndrome ductal breast carcinoma in situ Fibrosis Inflammation invasive breast carcinoma Radiation Fibrosis Syndrome

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.