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

NCT07771881 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-08-18

No results posted yet for this study

Summary

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).

Conditions

  • Thrombocytopenia Chemotherapy Induced

Interventions

DRUG

Romiplostim N01

Romiplostim N01 for Injection: 3.0 µg/kg, QW. If the administration coincides with a chemotherapy day, the Romiplostim N01 for injection should be completed within 2 hours prior to chemotherapy. If no chemotherapy is scheduled on the planned dosing day, the injection timing is unrestricted. Thereafter, platelet counts should be monitored once or twice weekly. Subsequent dose adjustments follow the principle of guideline-based titration: when platelet count is \<50×10⁹/L, the dose is increased by 1-2 µg/kg per week; when platelet count is between 50×10⁹/L and 75×10⁹/L, the dose is increased by 1 µg/kg per week. Treatment should be discontinued if Romiplostim N01 for injection at 10 µg/kg administered weekly for 4 consecutive weeks fails to achieve a response. Non-response is defined as a platelet count ≤75×10⁹/L after 4 weeks of continuous administration, accompanied by an increase from baseline of ≤30×10⁹/L over the same period.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-04-30
Completion
2030-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771881 on ClinicalTrials.gov