Actively Recruiting
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Led by Fujian Medical University Union Hospital · Updated on 2025-08-08
214
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
F
Fujian Medical University Union Hospital
Lead Sponsor
B
Beijing Continent Pharmaceutical Co, Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Histologically confirmed breast invasive carcinoma or ductal/lobular carcinoma in situ
- Eastern Tumor Cooperative Group (ECOG) physical status score of 0 to 2
- Meeting indications for postoperative radiotherapy and neoadjuvant chemotherapy based on clinical or pathological staging
- Radiotherapy regimen of chest wall plus supraclavicular 40Gy/15f after root modification, or whole breast ± upper and lower clavicular 40Gy/15f after breast preservation, with tumor bed simultaneous supplement 50Gy/15f
- Laboratory tests within 28 days prior to enrollment meeting blood and biochemical criteria: Hb≥90g/L; ANC≥1.5×10⁹/L; PLT≥70×10⁹/L; TBIL <1.5×ULN; ALT and AST ≤2.5×ULN; Serum creatinine ≤1.25×ULN or creatinine clearance ≥45 mL/min
- Negative serum pregnancy test within 7 days before first dose for women at risk of pregnancy and agreement to use effective contraception during and for 120 days after the trial
- Voluntary informed consent, good compliance, and willingness to cooperate with follow-up
You will not qualify if you...
- Male breast cancer patients
- Patients refusing or not meeting conditions for large segmentation radiotherapy
- Active, known, or suspected autoimmune disease unless stable and not requiring systemic immunosuppressive therapy
- Participation in another clinical study or within 4 weeks of completing a previous study
- Known or suspected history of interstitial pneumonia or conditions interfering with pulmonary toxicity assessment
- History of other malignant tumors unless disease-free for 5 years after curative treatment
- Pregnant women and patients with mental illness
- Prior treatment with radiotherapy or chemotherapy
- Active tuberculosis or severe lung infections needing systemic treatment
- Significant blood coughing or daily hemoptysis ≥2.5 mL within 2 months before randomization
- Heart failure (NYHA class III or IV), poorly controlled coronary artery disease, arrhythmia, or recent myocardial infarction within 6 months
- Known HIV infection or AIDS
- Untreated active hepatitis B or C infection or co-infection
- Other serious diseases, laboratory abnormalities, or social factors that may affect safety or study data collection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
Research Team
Y
Yong Yang, Doctor
CONTACT
D
Daxin Huang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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