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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Minor Study Identification, Study Statusv5
  2. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2024 to May 31, 2026
    v4
  3. Notable Primary completion date: Jan 31, 2024 to Dec 31, 2024
    • Study completion date: May 31, 2024 to Dec 31, 2024
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 27, 2023 to Mar 16, 2023
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05704166
Lead Sponsor Fujian Medical University Union Hospital
Collaborators: Beijing Continent Pharmaceutical Co, Ltd.
Conditions
(from sponsor)
Acute Lung Injury, Prevention
Related terms Acute Lung Injury, Breast Neoplasms
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov