Romiplostim Biosimilar (Qilu Pharma)

The primary study objective:
To evaluate the efficacy of romiplostim (N01) in the treatment of chemotherapy-induced thrombocytopenia (CIT) in breast cancer patients by assessing the proportion of patients whose platelet count recovers to ≥100×10⁹/L after two weeks of treatment.
This study is a multicenter, single-arm, interventional trial. It plans to enroll 68 breast cancer patients with chemotherapy-induced thrombocytopenia (CIT) (PLT <75×10⁹/L).
The study comprises a Screening Period (from after the subject signs the informed consent form until before the first dose), a Treatment Period (including treatment with romiplostim N01), and a Follow-up Period.
Screening Period: Subjects will be evaluated against the inclusion and exclusion criteria. Those who qualify may proceed to the Treatment Period.
Treatment Period: Eligible subjects from screening will undergo a baseline visit and will receive romiplostim N01 once weekly for a maximum of 4 weeks. Dosing will be stopped when the platelet count increases to ≥100×10⁹/L. When a subject resumes anti-tumor therapy, prophylactic administration of romiplostim N01 (administered 2 hours prior to anti-tumor therapy) will be performed for subjects with a baseline platelet level of <50×10⁹/L before the administration of the anti-tumor therapy drugs.
Dosage Regimen:
Romiplostim N01: 200 μg per dose, administered subcutaneously, once weekly.
Follow-up Period: Subjects will enter the Follow-up Period after the completion of the treatment.