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Recruiting INTERVENTIONAL 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

Sponsor: Shaw Cancer Center

Updated 6 times since 2023 Last updated: Apr 21, 2026 Started: Aug 17, 2023 Primary completion: Aug 17, 2027 Completion: Aug 17, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Radiation Induced Fibrosis and is currently actively recruiting participants. Shaw Cancer Center leads this study, which shows 6 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2023 – ~Nov 2023 · 10 months · monthly snapshotNot Yet Recruiting~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshotRecruiting~Oct 2024 – ~Apr 2026 · 19 months · monthly snapshotRecruitingApr 28, 2026 – present · 2 months · daily APIRecruiting

Change History

6 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Recruiting

    Phase: PHASE2None

  2. Oct 2024 — Apr 2026 [monthly]

    Recruiting PHASE2

  3. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. Nov 2023 — Jul 2024 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

Show 1 earlier version
  1. Jan 2023 — Nov 2023 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Shaw Cancer Center
  • Steadman Philippon Research Institute
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations