CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 43 target
Drug / intervention
Losartan 25 milligram capsule +1 moredrug
Likely dose
Losartan 25 milligram capsulefrom record
Key inclusion· 6
  • ✓Diagnosed with clinical or pathologic stage 0-IV invasive breast cancer including DCIS, TX, and T1-T4
  • ✓Has been treated with breast conserving surgery or mastectomy with reconstruction
  • ✓Candidate for unilateral post-surgery radiation therapy per NCCN guidelines
  • ✓Age ≥ 18 years
Key exclusion· 22
  • ✕Recurrent breast cancer and history of prior breast radiation therapy
  • ✕Requires bilateral breast/chest wall radiation therapy
  • ✕Undergoing concurrent chemotherapy treatment
  • ✕Documented fall risk

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05637216
NCT05637216Phase 2ActiveOn Track
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A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Shaw Cancer Center·interventional·Posted Dec 5, 2022·Updated Jun 18, 2026

In Brief

A Phase 2 clinical trial evaluating Losartan 25 milligram capsule and Placebo for Radiation Induced Fibrosis. Active but no longer recruiting, targeting 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRadiation Induced Fibrosis
CountriesUnited States
CollaboratorsSteadman Philippon Research Institute

Timeline

Phase 2Active
20232024202520262027
First PostedDec 5, 2022
Enrollment StartAug 17, 2023
Primary CompletionAug 17, 2027
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 3.6 years agoPrimary completion in 1.1 years

Arms & Interventions

Breast Conservation Surgery with Losartanexperimental

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.

Drug: Losartan 25 milligram capsule
Breast Conservation Surgery with Placeboplacebo_comparator

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.

Drug: Placebo
Mastectomy with Losartanexperimental

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.

Drug: Losartan 25 milligram capsule
Mastectomy with Placeboplacebo_comparator

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.

Drug: Placebo

Interventions

Losartan 25 milligram capsuledrug

Losartan 25 milligram oral capsule

Placebodrug

Placebo 25 milligram oral capsule