OncoMatch/Clinical Trials/NCT05704166
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Is NCT05704166 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for acute lung injury.
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
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage III, YPT3-T4, PT3-T4, PN2
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.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiotherapy
Prior treatment with radiotherapy, chemotherapy, etc.
Cannot have received: chemotherapy
Prior treatment with radiotherapy, chemotherapy, etc.
Lab requirements
Blood counts
hb ≥ 90 g/l; anc ≥ 1.5×10^9/l; plt ≥ 70×10^9/l
Kidney function
serum cr ≤ 1.25× uln or endogenous creatinine clearance ≥ 45 ml/min (cockcroft-gault formula)
Liver function
tbil < 1.5× uln; alt and ast ≤ 2.5 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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