Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Conditions

• Radiation Induced Fibrosis

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Losartan 25 milligram capsule — DRUG
  Losartan 25 milligram oral capsule
• Placebo — DRUG
  Placebo 25 milligram oral capsule

Study Details

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.

Key Dates

Start date

Aug 17, 2023

Status verified

Apr 2026

Primary completion

Aug 17, 2027

Completion

Aug 17, 2027

Study Design

Enrollment

43 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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.

Primary Outcome Measure

Fibrosis of the breast or reconstructed breast in irradiated breast cancer patients [ Time Frame: Baseline, 3-, 6-, 12- and 18- month follow up visits ]

Central Contacts

• Katie Hess, BS
  (970) 485-7874
  [email protected]
• Paige Bordelon, MPH
  (970) 569-7806
  [email protected]

Locations (1)

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