Actively Recruiting
Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
Led by Shaw Cancer Center · Updated on 2026-04-24
43
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Shaw Cancer Center
Lead Sponsor
S
Steadman Philippon Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with clinical or pathologic stage 0-IV invasive breast cancer including ductal carcinoma in situ (Tis), TX, and T1-T4
- Treated with breast conserving surgery or mastectomy with reconstruction
- Candidate for unilateral post-surgery radiation therapy per NCCN guidelines
- Female
- Age 18 years or older
- Laboratory values: AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Creatine ≤ 1.5 x ULN, eGFR ≥ 60
You will not qualify if you...
- History of recurrent breast cancer or prior breast radiation therapy
- Breast cancer requiring bilateral breast/chest wall radiation therapy
- Receiving concurrent chemotherapy
- Documented fall risk
- Active diagnosis of connective tissue disorder, rheumatoid arthritis, or systemic lupus erythematosus
- Uncontrolled illnesses such as hyperkalemia, impaired renal function, symptomatic congestive heart failure, unstable angina, kidney disease, uncontrolled diabetes, cystic fibrosis, or fibromyalgia
- Current use of losartan, other renin-angiotensin system agents, potassium-increasing agents, lithium, or aliskiren for diabetes
- Known allergy to any ingredient in losartan
- Unable to tolerate oral medication
- Pregnant, breastfeeding, or planning pregnancy within one year following radiation
- History or evidence of interstitial lung disease
- Any medical condition or findings that pose risk or interfere with study participation
- Known DNA gene mutations including ATM, RAD21, or C-509T in TGF-β1 gene
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vail Health Shaw Cancer Center
Edwards, Colorado, United States, 81632
Actively Recruiting
Research Team
K
Katie Hess, BS
CONTACT
P
Paige Bordelon, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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