NCT07771881尚未招募2 期
A Prospective Clinical Study on the Efficacy and Safety of Romiplostim N01 for Injection for Secondary Prophylaxis in Breast Cancer Patients With Chemotherapy-Induced Thrombocytopenia (CIT)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving response
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form.
- •Age 18 to 75 years, either sex.
- •Histologically or pathologically confirmed breast cancer.
- •Nadir platelet count <50×10⁹/L in the previous treatment cycle; OR nadir platelet count ≥50×10⁹/L but <75×10⁹/L in the previous chemotherapy cycle, plus at least one high-risk factor for bleeding as defined in the relevant guideline.
- •Platelet count >100×10⁹/L at screening.
- •No prior exposure to romiplostim/romiplostim N
- •Prior receipt of one or more antineoplastic therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, and immunotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Life expectancy of ≥12 weeks.
排除标准
- •Concomitant hematologic disorders;
- •Prior radiation therapy to long bones or flat bones, or currently receiving/planned to receive radiation therapy (local radiation to the breast is permitted);
- •Serious cardiac clinical symptoms or diseases within 6 months prior to screening;
- •Thrombotic predisposition or currently receiving thrombolytic and/or anticoagulant therapy;
- •Clinically significant bleeding symptoms within 2 weeks prior to screening, or definitive clinical manifestations of bleeding tendency;
- •Complications requiring emergency treatment, such as superior vena cava syndrome or spinal cord compression;
- •Significantly abnormal hepatic function: for patients without hepatic metastasis, ALT/AST >3×ULN and TBIL >3×ULN; for patients with hepatic metastasis, ALT/AST ≥5×ULN and TBIL ≥5×ULN;
- •Renal function abnormality: serum creatinine ≥1.5×ULN or eGFR ≤60 mL/min (by Cockcroft-Gault formula);
- •Receipt of romiplostim within 2 to 3 weeks prior to study drug administration;
- •Known or suspected hypersensitivity or intolerance to romiplostim N01 or its excipients (including cellulose-lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate);
- •HIV infection;
- •Participation in any other clinical study of an investigational drug or device within 3 months prior to screening;
- •Pregnant or lactating women;
- •Any other condition that, in the investigator's opinion, may affect study results or lead to premature discontinuation of the study.
结局指标
主要结局
Proportion of patients achieving response
时间窗: up to the completion of two consecutive treatment cycles, an average of 6 weeks
Defined as platelet recovery over two consecutive cycles, with no dose modification (≥15% reduction, ≥4-day delay, or discontinuation) due to thrombocytopenia, and no rescue treatment.
次要结局
- Proportion of patients with platelet count <50×10⁹/L per cycle(until the end of each treatment cycle, an average of 3 weeks)
- Minimum and maximum platelet counts(through study completion, an average of 1year)
- Number of symptomatic bleeding episodes during the treatment period(through study completion, an average of 1year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(through study completion, an average of 1year)
研究者
Zhimin Shao
Director of the Department of Breast Surgery, Fudan University Shanghai Cancer Center
Fudan University
研究点 (1)
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