NCT07257809招募中2 期
A Multicenter, Single-arm Exploratory Clinical Study Evaluating the Efficacy and Safety of T-DM1 in Patients With Breast Cancer Who Developed Thrombocytopenia.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年10月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Proportion of grade I thrombocytopenia according to CTCAE4.0
研究概览
简要总结
This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L) through intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment group A
Experimental
Herombopag， initial dose 7.5 mg po qd d1-14
干预措施: Herombopag Olamine Tablets (Drug)
结局指标
主要结局
Proportion of grade I thrombocytopenia according to CTCAE4.0
时间窗: From enrollment to the end of treatment at 6 weeks
The proportion of patients with platelet counts \<100 × 109/L according to CTCAE4.0
次要结局
- the proportion of salvage platelet transfusion therapy(From enrollment to the end of treatment at 6 weeks)
- time to platelet counts ≥100 × 109/L(From enrollment to the end of treatment at 6 weeks)
- Proportion of T-DM1with unexpected administration(From enrollment to the end of treatment at 6 weeks)
- proportion of adverse events(From enrollment to the end of treatment at 6 weeks)
研究者
Yinduo Zeng
chief physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究点 (1)
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