Using Losartan to Reduce Radiation-Induced Fibrosis in Breast Cancer Patients
A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
This study is testing if the medication losartan can help breast cancer patients reduce scarring caused by radiation treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shaw Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Edwards, Colorado) |
| Trial ID | NCT05637216 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of losartan, an FDA-approved medication that blocks transforming growth factor beta-1 (TGF-β1), in reducing radiation-induced fibrosis (RIF) in breast cancer patients. Conducted at the Vail Health Shaw Cancer Center, the study employs a double-blinded, placebo-controlled, randomized phase II design. Participants will be randomly assigned to receive either losartan or a placebo starting on the first day of radiation therapy, continuing for one year after treatment. The study aims to assess outcomes related to fibrosis, cosmetic results, and the need for reoperation over an 18-month period following radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older diagnosed with invasive breast cancer who are undergoing unilateral post-surgery radiation therapy.
Not a fit: Patients with recurrent breast cancer, those requiring bilateral radiation therapy, or those undergoing concurrent chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for breast cancer patients by reducing the incidence of radiation-induced fibrosis.
How similar studies have performed: While the approach of using losartan for this specific indication is novel, similar studies targeting fibrosis reduction have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Edwards, Colorado
- Vail Health Shaw Cancer Center — Edwards, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Patricia H Hardenbergh, MD — Vail Health Shaw Cancer Center
- Study coordinator: Katie Hess, BS
- Email: katherine.hess@vailhealth.org
- Phone: (970) 485-7874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.