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Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

NCT05637216 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Radiation Induced Fibrosis

Interventions

DRUG

Losartan 25 milligram capsule

Losartan 25 milligram oral capsule

DRUG

Placebo

Placebo 25 milligram oral capsule

Sponsors & Collaborators

  • Steadman Philippon Research Institute

    collaborator OTHER

  • Shaw Cancer Center

    lead OTHER

Principal Investigators

  • Patricia H Hardenbergh, MD · Vail Health Shaw Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2027-08-17
Completion
2027-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05637216 on ClinicalTrials.gov