Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Radiation Induced Fibrosis

In brief

This study will evaluate the efficacy of losartan (LOS), an FDA-approved transforming growth factor beta-1 (TGF-β1) blocker, to decrease radiation induced fibrosis (RIF) in the breast and the lung of breast cancer patients, testing the hypothesis that Losartan will decrease RIF, TGF- β1 and cellular senescence/inflammation in the breast and the lung of irradiated breast cancer patients relative to placebo treatment and consequently improve clinical outcomes in breast cancer patients.

Key facts

Study ID

NCT05637216

Run by

Shaw Cancer Center

People needed

43

Starts

2023-08-17

Expected to finish

2027-08-17

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Vail Health Shaw Cancer Center — Edwards, Colorado, United States

Full record on ClinicalTrials.gov

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