NCT07162519

Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients

A Prospective, Single-arm, Multicenter Clinical Study of Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 ≥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.

Conditions

• Cytotoxic Drugs
• Romiplostim N01
• Breast Cancer

Interventions

Type	Name	Description
DRUG	romiplostim N01	Eligible subjects who pass the screening will undergo a baseline visit and will receive romiplostim N01 administration once weekly for a maximum of 4 weeks. Dosing will be discontinued when the platelet count rises to ≥100×10⁹/L. When a subject resumes anti-tumor therapy, those with a baseline platelet count of \<50×10⁹/L will receive prophylactic administration of romiplostim N01 (administered 2 hours prior to anti-tumor therapy) before the anti-tumor drugs are given.

Timeline

• Start date: 2025-09-20
• Primary completion: 2026-08-30
• Completion: 2026-11-30
• First posted: 2025-09-09
• Last updated: 2025-09-09