NCT02137083已完成2 期
A Prospective Single-center Randomized Phase 2 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer
详细描述
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal female between 18 and 70 years old
- •ECOG performance status of ≤ 1
- •Life expectancy more than 3 months
- •Histologically confirmed metastatic breast cancer
- •ER and&or PR pqositive, HER2-negative
- •Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone
- •No pretreated chemotherapy for metastatic disease
- •Have at least one target lesion according to RECIST 1.1
- •No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment
- •Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>50ml/min
排除标准
- •Pregnant or lactating women
- •Evidence of CNS metastasis
- •Seriously uncontrolled infection
- •History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pretreated with Fulvestrant
- •Pretreated with two or more lines of endocrine therapy
研究组 & 干预措施
Docetaxel Plus Fulvestrant
Experimental
Docetaxel:75mg/m2 D2 every 21 days
Fulvestrant:500mg D1, D15, D29, D57, every 28 days later
干预措施: Docetaxel (Drug)
Docetaxel Plus Fulvestrant
Experimental
Docetaxel:75mg/m2 D2 every 21 days
Fulvestrant:500mg D1, D15, D29, D57, every 28 days later
干预措施: Fulvestrant (Drug)
Docetaxel
Active Comparator
Docetaxel:75mg/m2 D2 every 21 days
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 6 weeks
次要结局
- Overall Response Rate(6 Weeks)
- Overall Survival(6 Weeks)
研究者
Xichun Hu
Vice Director of department of medical oncology
Fudan University
研究点 (1)
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