Back to search results

Losartan for Radiation-Induced Fibrosis in Breast Cancer Patients

This study is testing if Losartan, an FDA-approved medication, can reduce radiation-induced fibrosis (scarring) in the breast and lung of breast cancer patients. Fibrosis can be a side effect of radiation therapy. Researchers believe Losartan might work by blocking a protein called TGF-β1, which is involved in scarring and inflammation. You may be eligible if you are a woman aged 18 or older with breast cancer who has had surgery (breast-conserving surgery or mastectomy with reconstruction) and is scheduled for radiation therapy. The study will measure fibrosis in the breast and lung, as well as levels of certain markers in your blood, to see if Losartan is effective. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with 43 participants. Participants will be divided into four groups, with some receiving Losartan and others receiving a placebo.
What's involved
You would take a 25mg capsule of Losartan or placebo by mouth once daily, starting on the day you begin radiation therapy and continuing for one year after radiation ends. You will have follow-up visits at baseline, 3, 6, 12, and 18 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 18 months after completing radiation therapy to assess fibrosis, cosmetic outcomes, and any need for further surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05637216

Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Active, Not Recruiting
PHASE2Ages 18+InterventionalPrevention
Shaw Cancer Center
~43 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Losartan 25 milligram capsulePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fibrosis of the breast or reconstructed breast in irradiated breast cancer patients
Measured over Baseline, 3-, 6-, 12- and 18- month follow up visits
+2 more outcomes measured

Conditions

Radiation Induced Fibrosis

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Patricia H Hardenbergh, MD · PRINCIPAL_INVESTIGATOR · Vail Health Shaw Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Fibrosis of the breast or reconstructed breast in irradiated breast cancer patientsBaseline, 3-, 6-, 12- and 18- month follow up visits

    Fibrosis will be assessed by a radiation oncology provider using the Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) (LENT-SOMA) scale. 0=Fibrosis absent, not detectable. 1=Fibrosis is Barely Palpable; 2=Definite increased density; 3=Very marked density, retraction and firmness and fixation

  • Radiographic lung fibrosis in the radiation field of irradiated breast cancer patientsBaseline, 3- and 12- month follow up visits

    Radiographic lung fibrosis will be assessed with high resolution CT scans of the thorax. Thorax CT scans will be fused to the radiation planning CT scan for confirmation of the overlap of fibrosis with the radiation field.

  • Average levels of cellular senescence, transforming growth factor beta-1 (TGF-β1) and senescence-associated secretory phenotype (SASP) serum biomarkersBaseline, day of last radiation therapy fraction, 3- and 12- month follow up visits

    Cellular senescence, and senescence-associated secretory phenotype (SASP) including TGF-β and inflammation will be quantified in the treatment and control group. A novel and expert approach to measure senescent cells in serum will be utilized.