Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer P… (NCT07162519) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients
68 participantsStarted 2025-09-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form must be obtained prior to enrollment;
✓. Aged 18-75 years;
✓. Patients with histologically or pathologically confirmed breast cancer;
✓. Breast cancer patients with chemotherapy-induced thrombocytopenia (CTIT);
✓. No prior treatment with romiplostim or romiplostim N01 within 3 months;
✓. ECOG PS score: 0-2;
✓. Platelet count \<75×10⁹/L;
✓. Expected survival period ≥12 weeks at screening;
Exclusion criteria
✕. Presence of hematopoietic system diseases other than chemotherapy-induced thrombocytopenia (CIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndromes;
✕. Platelet reduction due to causes other than CIT within 6 months prior to screening, including but not limited to chronic liver disease, hypersplenism, infection, or hemorrhage;
What they're measuring
1
2-week response rate
Timeframe: 2 weeks
Trial details
NCT IDNCT07162519
SponsorTianjin Medical University Cancer Institute and Hospital
✕. Bone marrow infiltration or bone marrow metastasis;
✕. Prior radiotherapy to the pelvis, spine, or large-field bone irradiation within 3 months before screening, or current/scheduled radiotherapy;
✕. History of severe cardiovascular diseases within 6 months prior to screening, such as congestive heart failure (NYHA Class III-IV), arrhythmias known to increase thromboembolic risk (e.g., atrial fibrillation), post-coronary stent implantation, angioplasty, or coronary artery bypass grafting;
✕. Clinical manifestations of severe hemorrhage within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding;
✕. Brain tumors or brain metastases;
✕. Conditions requiring emergency treatment, such as superior vena cava syndrome or spinal cord compression;