Phase II Extension Study of E7389 for Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Number of Subjects With Adverse Events.
研究概览
简要总结
The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.
详细描述
Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224. Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data. Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 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
研究组 & 干预措施
Eribulin Mesylate
干预措施: Eribulin Mesylate (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events.
时间窗: Every week during treatment and up to 30 days after last dose of study treatment
次要结局
- Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)(Every 6 weeks)