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

August 4, 2025 updated by: Yong Yang, Fujian Medical University Union Hospital

Pirfenidone Versus Placebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following Hypofractionated Radiotherapy in Breast Cancer Patients (PRILI): A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.In this study, the incidence of grade 1-4 radiation lung injury was expected to be 60% in the radiotherapy alone group (placebo group), and pirfenidone capsules (experimental group) were expected to reduce the incidence of lung injury after radiotherapy to 40%. Bilateral test showed a statistical efficacy of 0.8 (α option 0.05). In this study, two independent rate comparison sample sizes were used to calculate, Binomial Enumeration method was used for 97 patients in both groups, and the expected shedding rate was 10%. 107 patients were needed in each group, and the total sample size was 214. Biological specimens are expected to be obtained from more than 100 patients.

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be enrolled in this study, patients must meet all of the following inclusion criteria:

    1. Breast invasive carcinoma or ductal carcinoma in situ or lobular carcinoma in situ confirmed by histology;
    2. Age 18-75, female;
    3. The physical state score of the Eastern Tumor Cooperative Group (ECOG) was 0-2;
    4. Patients meeting the indications of postoperative radiotherapy and neoadjuvant chemotherapy: clinical stage 3 or above or postoperative ypT3-T4 or N+; Non-neoadjuvant chemotherapy patients: postoperative pathological staging of pT3-T4 or pN2 or above, or positive for upper and lower clavicle and lymph nodes in the internal milk region, or positive for clinical consideration; For patients with pT1-2N1, postoperative adjuvant radiotherapy should be determined based on the patient's age, tumor grade, incisal margin, number of positive lymph nodes, molecular typing, past complications, and patient's intention.
    5. Radiotherapy regimen was chest wall + supraclavicular 40Gy/15f after root modification, or whole milk ± upper and lower clavicular 40Gy/15f after breast preservation, tumor bed simultaneous supplement 50Gy/15f;

    6. All screening period laboratory tests should be performed in accordance with protocol requirements and within 28 days prior to enrollment. The values of laboratory tests performed by screening must meet the following criteria:

      blood routine check all meet the following criteria: A. Hb≥90g/L; B. ANC≥1.5×109/L; C. PLT≥70×109/L; biochemical examination all meet the following criteria: TBIL < 1.5× upper limit of normal range (ULN); ALT and AST≤2.5 x ULN; Serum Cr≤1.25×ULN or endogenous creatinine clearance ≥45 mL/min (Cockcroft-Gault formula)

    7. Women who are at risk of becoming pregnant must undergo a negative serum pregnancy test within 7 days before the first dose and be willing to use a highly effective method of contraception during the trial period and 120 days after the last dose of the test drug. Male subjects with a partner of a woman of reproductive age should be surgically sterilized or consent to a highly effective method of contraception during the trial period and 120 days after the last test drug administration;
    8. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

  • Patients with any of the following criteria were not enrolled in this study

    1. History and complications A. male breast cancer patients; B. Did not meet the conditions of large segmentation radiotherapy (upper and lower clavicular lymph node metastasis, internal milk lymph node metastasis, the patient refused large segmentation radiotherapy); C. The subject has any active, known, or suspected autoimmune disease. To admit subjects who are in a stable state and do not require systemic immunosuppressive therapy; D. The patient is participating in another clinical study or less than 4 weeks after the end of the previous clinical study; E. Patients with a known or highly suspected history of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; F. A history of other malignant tumors; Except in patients who have had potentially curable therapy and have not had disease recurrence for 5 years since treatment began; G. Pregnant women and patients with mental illness; H. Prior treatment with radiotherapy, chemotherapy, etc.; I. Patients with active tuberculosis should be excluded; J. Severe acute or chronic lung infections requiring systemic treatment; K. Patients with obvious blood coughing or daily hemoptysis of half a teaspoon (2.5ml) or more in the 2 months before randomization; L. Patients with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction in the 6 months prior to screening despite receiving appropriate medication.
    2. Physical examination and laboratory examination A. A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS); B. untreated active hepatitis (hepatitis B: HBsAg positive with HBV DNA≥ 500 IU/mL; Hepatitis C: HCV RNA positive and abnormal liver function); Combined with hepatitis B and hepatitis C co-infection.
    3. As determined by the investigator, the patient may have other factors that may lead to the termination of the study, such as other serious diseases or serious abnormalities in laboratory tests or other factors that may affect the safety of the subjects, or family or social factors such as the collection of test data and samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pirfenidone
Patients were given placebo or pirfenidone capsules orally one week before radiotherapy, 200mg/ time, 3 times a day in the first week; 300mg/ time 3 times daily for the second week and 400mg/ time 3 times daily for the third to eighth week. Take it after a meal.
Drug: Pirfenidone/Placebo
Patients were given drugs orally one week before radiotherapy, 200mg/ time, 3 times a day in the first week; 300mg/ time 3 times daily for the second week and 400mg/ time 3 times daily for the third to eighth week. Take it after a meal.
Other Names:
  • Pirfenidone Capsules/Placebo
Placebo Comparator: Placebo
Patients were given placebo or pirfenidone capsules orally one week before radiotherapy, 200mg/ time, 3 times a day in the first week; 300mg/ time 3 times daily for the second week and 400mg/ time 3 times daily for the third to eighth week. Take it after a meal.
Drug: Pirfenidone/Placebo
Patients were given drugs orally one week before radiotherapy, 200mg/ time, 3 times a day in the first week; 300mg/ time 3 times daily for the second week and 400mg/ time 3 times daily for the third to eighth week. Take it after a meal.
Other Names:
  • Pirfenidone Capsules/Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in lung injury grading on chest computerized tomography within 3 months after radiotherapy
Time Frame: 4 weeks and 12 weeks after radiotherapy
Kouloulias scale was used to evaluate the changes of lung injury grading in chest computerized tomography within 3 months after radiotherapy. The higher the grading is, the more serious the lung injury is
4 weeks and 12 weeks after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between biomarkers and radioactive damage
Time Frame: 1 week before medication，4 weeks and 12 weeks after radiotherapy
The changes of the above cytokines in the blood of patients were monitored before and after radiotherapy, and the correlation between the changes of cytokines and the grade of radiation damage was analyzed
1 week before medication，4 weeks and 12 weeks after radiotherapy
Relationship between biomarkers and therapy
Time Frame: 1 week before medication，4 weeks and 12 weeks after radiotherapy
The changes of the above cytokines in the blood of patients were monitored before and after radiotherapy, and the correlation between the changes of cytokines and treatment was analyzed
1 week before medication，4 weeks and 12 weeks after radiotherapy
security
Time Frame: Every week of the medication，4 weeks and 12 weeks after radiotherapy
use the CTCAE5.0 scale to record adverse events to assess safety
Every week of the medication，4 weeks and 12 weeks after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Collaborators

Beijing Continent Pharmaceutical Co, Ltd.

Investigators

  • Principal Investigator: Yong Yang, Doctor, Director of the radiotherapy department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMUUH-BC-2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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