Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients
Status:
NOT_YET_RECRUITING
Trial end date:
2026-11-30
Target enrollment:
Participant gender:
Summary
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 10010/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 \<7510/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 10010/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 \<5010/L before the administration of the anti-tumor therapy drugs.
Dosage Regimen:
Romiplostim N01: 200 g per dose, administered subcutaneously, once weekly.
Follow-up Period: Subjects will enter the Follow-up Period after the completion of the treatment.
Phase:
NA
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborators:
Affiliated Hospital of Hebei University Shandong Cancer Hospital and Institute Tangshan People's Hospital Union Hospital, Tongji Medical College, Huazhong University of Science and Technology