Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
Radiation Induced Fibrosis
About this trial
This is an interventional prevention trial for Radiation Induced Fibrosis focused on measuring losartan, radiation, fibrosis, cosmesis, reoperation, TGFB1, Transforming growth factor beta 1 (TGF-β1), Angiotensin II Receptor Blockers, ace inhibitor, Angiotensin-converting enzyme (ACE) inhibitors, TGF-β1, antifibrotic, signaling pathway, breast cancer, TGF beta, radiation induced fibrosis, irradiation fibrosis, Radiation injury with fibrosis, Transforming growth factor beta 1, Inflammation, Biomarker, Suppressor of Mothers against Decapentaplegic (SMAD)
Eligibility Criteria
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 or history of prior breast radiation therapy Breast cancer requiring bilateral breast/chest wall radiation therapy Undergoing concurrent chemotherapy treatment Documented fall risk Active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism requiring hormone replacement only, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of a systemic inflammatory arthritis such as psoriatic, rheumatoid, systemic lupus, ankylosing spondylitis or reactive arthritis Uncontrolled intercurrent illness including, but not limited to: 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 The presence of interstitial lung disease on baseline CT scan 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
Sites / Locations
- Vail Health Shaw Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Breast Conservation Surgery with Losartan
Breast Conservation Surgery with Placebo
Mastectomy with Losartan
Mastectomy with Placebo
Participants who underwent breast conservation surgery will take losartan in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.
Participants who underwent breast conservation surgery will take placebo in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.
Participants who underwent a mastectomy will take losartan in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.
Participants who underwent a mastectomy will take placebo in a 25 milligram oral capsule once daily starting day one of radiation therapy until one year following the completion of radiation therapy.