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
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
- 否
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
研究点 (34)
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