NCT05637216

Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shaw Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This single site study will be conducted at the Vail Health Shaw Cancer Center in Edwards, Colorado. A block, double-blinded, placebo-controlled, randomized phase II design will be utilized . Study participants will be blocked by surgical intervention (breast conserving surgery vs. mastectomy) and then randomized, 1:1, into the treatment and control arms for a total of four study arms. The research team and study participants will be blinded to the study arm and a placebo will be used to reduce detection bias in the reporting of outcomes. Selection bias will be minimized through the randomization of study arms. Study participants will be prescribed 25mg capsules of placebo or the investigational drug, Losartan, to be taken by mouth once daily. The treatment start date will be the day that subject begins radiation therapy. Radiation therapy will continue to be prescribed in accordance with local clinic procedures. Treatment with the study intervention will continue for one year upon completion of radiation therapy. All participants will be assessed for fibrosis, cosmetic outcomes, and incidence of reoperation for 18 months following the completion of radiation therapy.

Conditions

• Radiation Induced Fibrosis

Interventions

Type	Name	Description
DRUG	Losartan 25 milligram capsule	Losartan 25 milligram oral capsule
DRUG	Placebo	Placebo 25 milligram oral capsule

Timeline

• Start date: 2023-08-17
• Primary completion: 2027-08-17
• Completion: 2027-08-17
• First posted: 2022-12-05
• Last updated: 2024-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study