A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Estimate the effect of ZD1839 compared with placebo on the change in tumour cell proliferation in patients who have completely ER negative & PgR negative breast cancer
研究概览
简要总结
This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed ER- and PgR- primary breast cancer
- •Stage T .5 cm, N0-1, M0
- •No previous treatment for breast cancer
排除标准
- •ALT or AST greater than 2.5 times the ULRR
- •Metastatic disease
结局指标
主要结局
Estimate the effect of ZD1839 compared with placebo on the change in tumour cell proliferation in patients who have completely ER negative & PgR negative breast cancer
Aassessment of biomarker Ki-67 in breast cancer tissue at baseline by core biopsy and after 4 weeks on the surgical specimen
次要结局
- To assess the effect of 4 weeks of ZD1839 on the change in tumour size as assessed by ultrasounds.
- To correlate the expression of tissue biomarkers (HER family and epidermal growth factor [EGF] related pathways) in the baseline biopsy sample and in the surgical (endpoint) specimen with the anti-proliferative effect of ZD1839.
- To determine the effect of ZD1839 on HER-2 phosphorylation and other biomarkers in the surgical (endpoint) specimens when compared with the baseline biopsies
- To assess the effect of ZD1839 on apoptosis as assessed by TUNEL in the surgical (endpoint) specimens when compared with the baseline biopsies
- To determine plasma trough concentrations of ZD1839 and correlate these with molecular biomarkers detected in breast cancer tissue.