NCT05255523尚未招募2 期
A Single Arm，Multicenter，Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Incidence of first progression with brain metastases
研究概览
简要总结
The purpose of this study is to assess the effect of pyrotinib
详细描述
The purpose of this study is to assess the effect of pyrotinib combined with trastuzumab in the maintenance phase delay/reduction of brain metastases after first-line TH(P) therapy for HER-2-positive advanced breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age:18-75 years old, female;
- •HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
- •Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Life expectancy greater than or equal to 6 months;
- •The main organs function well, and the inspection indicators meet the following requirements:
- •For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN;
- •The researchers believed that the subjects were preference to benefit;
- •Participants were willing to join in this study, and written informed consent.
排除标准
- •Patients with brain metastases by CT or MRI;
- •More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
- •Study drug and excipient allergy;
- •History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- •Pregnant or lactating female patients;
- •Less than 4 weeks from the last clinical trial;
- •The researchers think inappropriate.
研究组 & 干预措施
Arm 1
Experimental
Pyrotinib：400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle.
干预措施: pyrotinib (Drug)
结局指标
主要结局
Incidence of first progression with brain metastases
时间窗: 24 month
Incidence of first progression with brain metastases
次要结局
- TTBM(24 month)
- ORR without CNS(24 month)
研究者
相似试验
Unknown
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Unknown
2 期
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不适用
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已完成
2 期
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