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临床试验/EUCTR2006-000320-14-IT
EUCTR2006-000320-14-IT进行中(未招募)不适用

FACT anastrozole monotherapy versus maximal oestrogen blockade with anstrozole and fulvestrant combination therapy an open randomized, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localized tumour. - FACT

ASTRAZENECA0 个研究点目标入组 512 人开始时间: 2007年3月20日最近更新:
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
512

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 misurable or not misurable advanced disease 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:
  • 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

发起方
ASTRAZENECA

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