NCT02161315Unknown不适用
A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- RECIST 1.1
研究概览
简要总结
Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.
详细描述
A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be the postmenopausal women
- •Patients must be diagnosed with advanced breast cancer by imageology，cytology or histopathology
- •Immunohistochemistry shows ER and/or PR positive
- •Patients ECOG score must be 0-2
- •Drug resistant about Non-Steroid Aromatase Inhibitors
排除标准
- •Not suitable for endocrine therapy
- •Have receive the standard Steroid Aromatase Inhibitors treatment
- •Severe hepatic dysfunction
结局指标
主要结局
RECIST 1.1
时间窗: -7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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