Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions

Inclusion criteria

• Patients aged 18-70 years (inclusive), regardless of gender.
• Diagnosis \& Treatment Plan: Histopathologically confirmed early-stage or advanced breast cancer patients eligible for AC regimen (liposomal doxorubicin + cyclophosphamide) chemotherapy per clinical guidelines.
• ECOG Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Anticipated survival ≥3 months.
• Organ Function Requirements:
• Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L ,Platelet count ≥75 × 10⁹/L Hemoglobin ≥90 g/L
• Hepatic:
• Non-liver metastasis: Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN Liver metastasis: TBIL ≤1.5 × ULN ,ALT and AST ≤5 × ULN
• Renal:
• Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (Ccr) ≥50 mL/min
• Coagulation:
• International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN Activated partial thromboplastin time (APTT) ≤1.5 × ULN
• Contraception:
• Female patients: Must use effective contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative serum pregnancy test within 7 days prior to enrollment is required, and patients must be non-lactating.
• Male patients: Must agree to use contraception during the study and for 6 months after study completion.
• Informed Consent: Patients must voluntarily participate, provide signed informed consent, and comply with protocol-specified procedures (blood tests, follow-ups, etc.).

Exclusion criteria

• Received chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first study dose (or within 5 half-lives, whichever is shorter). Exceptions: The washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy to avoid prolonged patient waiting).
• Previous treatment with liposomal doxorubicin or similar formulations.
• Allergy History: Known hypersensitivity to liposomal products or doxorubicin.
• Cardiovascular Diseases:
• Severe arrhythmias/conduction abnormalities (e.g., clinically significant ventricular arrhythmias, second- or third-degree AV block).
• History of myocardial infarction, coronary artery bypass grafting (CABG), or heart failure (NYHA Class ≥II).
• LVEF ≤50%or prolonged QTcF (\>450 ms in males; \>470 ms in females).
• Active Infections: Grade ≥2 （NCI CTCAE v5.0）
• Immunosuppression:
• Active autoimmune diseases, immunodeficiency (e.g., HIV-positive), or congenital/acquired immune disorders.
• History of organ transplantation or chronic corticosteroid use.
• HBsAg-positive with HBV-DNA ≥500 IU/mL. Exception: If HBV-DNA \<500 IU/mL and chronic hepatitis is deemed stable/inactive by the investigator, enrollment is permitted.
• Other Infections: Positive for HCV antibody or syphilis-specific antibody.
• Neurological/Psychiatric Disorders: History of epilepsy, dementia, or other uncontrolled conditions.
• CNS Metastases: Symptomatic brain or leptomeningeal metastases, or uncontrolled CNS lesions. Exception: Asymptomatic brain metastases or lesions stable for ≥28 days without steroids/antitumor therapy are allowed.
• Any other condition that, per investigator assessment, may compromise patient safety or study compliance.
• Pregnant or breastfeeding women.
• Patients deemed ineligible for the study by the investigator.