Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer

This study aims to evaluate the efficacy and safety of Romiplostim N01 for Injection administered as secondary prophylaxis in breast cancer patients with chemotherapy-induced thrombocytopenia (CIT).

Inclusion Criteria: 1. Signed informed consent form. 2. Age 18 to 75 years, either sex. 3. Histologically or pathologically confirmed breast cancer. 4. Nadir platelet count \3×ULN and TBIL \>3×ULN; for patients with hepatic metastasis, ALT/AST ≥5×ULN and TBIL ≥5×ULN; 8. Renal function abnormality: serum creatinine ≥1.5×ULN or eGFR ≤60 mL/min (by Cockcroft-Gault formula); 9. Receipt of romiplostim within 2 to 3 weeks prior to study drug administration; 10. Known or suspected hypersensitivity or intolerance to romiplostim N01 or its excipients (including cellulose-lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate); 11. HIV infection; 12. Participation in any other clinical study of an investigational drug or device within 3 months prior to screening; 13. Pregnant or lactating women; 14. Any other condition that, in the investigator's opinion, may affect study results or lead to premature discontinuation of the study.