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临床试验/NCT00255463
NCT00255463已完成2 期

Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours

AstraZeneca34 个研究点 分布在 7 个国家目标入组 185 人开始时间: 2004年1月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
AstraZeneca
入组人数
185
试验地点
34
主要终点
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups

研究概览

简要总结

The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

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
Double

入排标准

性别
Female
接受健康志愿者

入选标准

  • Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
  • Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
  • Natural menopause with last menses > 1 year ago,
  • Radiation induced oophorectomy with last menses > 1 year ago,
  • Serum FSH and LH levels clearly in the postmenopausal range for the institution.
  • Bilateral oophorectomy

排除标准

  • Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
  • Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer

结局指标

主要结局

To determine and compare changes in proliferation marker at 16 weeks in the treatment groups

次要结局

  • Comparison of WHO and RECIST criteria,
  • Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
  • Exploratory biomarker studies involving genomics, metabolomics and proteomics.

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (34)

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