NCT00328120已完成1 期
An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- The primary objective of this study is to assess the tolerability of 500mg fulvestrant
研究概览
简要总结
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Postmenopausal woman who fulfils any one of the following criteria:
- •Histological or cytological confirmation of breast cancer
- •Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).
排除标准
- •Having received any one of the following therapy for advanced or recurrent breast cancer
- •2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
结局指标
主要结局
The primary objective of this study is to assess the tolerability of 500mg fulvestrant
时间窗: assessed when all patients have been in the study for 6 months
次要结局
- Pharmacokinetics(each visit)
- Time to progression(assessed when all patients have been in the study for 6 months)
- ORR(assessed when all patients have been in the study for 6 months)
- Clinical benefit rate(assessed when all patients have been in the study for 6 months)
- Time to response(assessed when all patients have been in the study for 6 months)
- duration of response and changes in serum tumour markers(assessed when all patients have been in the study for 6 months)
研究者
研究点 (5)
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