MedTrace Logo

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

NCT07162519 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-09-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Affiliated Hospital of Hebei University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Shandong Cancer Hospital and Institute

    collaborator OTHER

  • Tangshan People's Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-09-20
Primary Completion
2026-08-30
Completion
2026-11-30

More Related Trials

Entities

Diseases

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 NCT07162519 on ClinicalTrials.gov