Efficacy and Safety of Qibei Jiedu Formula for Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients

Inclusion Criteria: * Patients with pathologically confirmed unilateral stage I-III non-inflammatory breast cancer, having undergone breast-conserving surgery or modified radical mastectomy, and having received or planned to receive standard adjuvant therapy according to current clinical guidelines. * Scheduled to receive postoperative adjuvant radiotherapy using a hypofractionated regimen (40-50 Gy/15 fractions) as recommended by the NCCN Breast Cancer Guidelines and the CSCO Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition). * Meeting the TCM diagnostic criteria for the syndrome of Qi-Yin Deficiency with Blood Stasis and Toxin Accumulation. * Karnofsky Performance Status (KPS) score ≥70. * Age ≥18 years, female. * Voluntarily participating in the study and providing written informed consent. Exclusion Criteria: * Presence of grade 4 radiation dermatitis requiring urgent intervention at enrollment or during the study. * Prior radiotherapy to the breast or chest within the past 3 months. * Any skin condition that may interfere with the assessment of radiation dermatitis, such as active infection, atopic dermatitis, psoriasis, vitiligo, active collagen vascular disease (e.g., scleroderma, lupus erythematosus), or other known autoimmune disorders significantly altering skin appearance or physiological response. * Pre-existing grade ≥2 hepatic/renal dysfunction or hematological toxicity (according to CTCAE v5.0 criteria) before treatment. * Concurrent participat…