An Observational Post-Marketing Surveillance Study on the Status and Factors for the Development of Peripheral Neuropathy in Patients With HER2-Negative Inoperable or Recurrent Breast Cancer in Japan.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 651
- 主要终点
- Number of participants with adverse events and serious adverse events
研究概览
简要总结
The primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with adverse events and serious adverse events
时间窗: Baseline and up to 2 years after the initial dose of HALAVEN
Time to resolution of peripheral neuropathy
时间窗: Baseline and up to 2 years after the initial dose of HALAVEN
Number of participants with peripheral neuropathy
时间窗: Baseline, and every two months after the initial dose of HALAVEN up to 2 years
Common Terminology Criteria for Adverse Events (CTCAE) grade of peripheral neuropathy is assessed at baseline, and every two months after the initial dose of HALAVEN up to 2 years.
Number of participants with adverse drug reactions
时间窗: Baseline and up to 2 years after the initial dose of HALAVEN
Time to onset of peripheral neuropathy
时间窗: Baseline and up to 2 years after the initial dose of HALAVEN
次要结局
- Overall survival(Up to 2 years)