Clinical Trial

PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients

Recruiting Phase 2
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Record status
This record was last updated August 8, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The incidence of chest CT manifestations of lung injury after radiotherapy for breast cancer is more than 50%. Although the prognosis and quality of life of patients are rarely affected, it is still necessary to prevent the occurrence of minor radiation lung injury with the use of more novel drugs and subsequent salvage treatment may aggravate the radiation injury. This study intends to conduct a randomized, double-blind, single-center clinical study of pirfenidone versus placebo in the prevention of acute radiation induced lung injury after breast cancer surgery
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-01-19; most recent amendment 2025-08-04.
Status change: Not Yet Recruiting → Recruiting 2023-05-25
Trial Details
NCT Number NCT05704166
Lead Sponsor Fujian Medical University Union Hospital
Collaborators: Beijing Continent Pharmaceutical Co, Ltd.
Conditions Acute Lung Injury, Prevention
Enrollment 214 participants
Start Date 2023-03-16
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-08