A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
∙ Inclusion of Women and Minorities - Women of any race/ethnicity are eligible for this trial.
Locations
United States
Colorado
Vail Health Shaw Cancer Center
RECRUITING
Edwards
Contact Information
Primary
Katie Hess, BS
katherine.hess@vailhealth.org
(970) 485-7874
Backup
Paige Bordelon, MPH
paige.bordelon@vailhealth.org
(970) 569-7806
Time Frame
Start Date:2023-08-17
Estimated Completion Date:2027-08-17
Participants
Target number of participants:40
Treatments
Experimental: Breast Conservation Surgery with Losartan
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.
Placebo_comparator: Breast Conservation Surgery with Placebo
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.
Experimental: Mastectomy with Losartan
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.
Placebo_comparator: Mastectomy with Placebo
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.