EUCTR2005-002868-28-IT进行中（未招募）不适用
A Randomised, Open-Label, Parallel-Group, Multi-centre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500mg with Anastrozole (ARIMIDEX™) 1mg as First Line Hormonal Treatment for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer - FIRST STUDY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Postmenopausal woman
- •2.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue
- •3.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent
- •4.Histological/cytological confirmation of breast cancer
- •5.Provision of written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous systemic therapy for advanced breast cancer.
- •2.Platelets < 100 ´ 109 / L
- •3.Total bilirubin > 1.5 ´ ULRR (Upper limit of reference range)
- •4.ALT or AST transamminase > 2.5 ´ ULRR if no demonstrable liver metastases or > 5 ´ ULRR in presence of liver metastases
研究者
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