Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.
详细描述
This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.
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 (Participant, Investigator)
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
- •Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer.
- •Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial.
- •A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required.
排除标准
- •Patients cannot be on hormone replacement therapy while on study.
- •Prior chemotherapy received for metastatic disease is not allowed.
- •Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed.
- •Patients who have evidence of an active interstitial lung disease are not eligible.
研究组 & 干预措施
Anastrozole-placebo
Anastrozole (ZD1033, Arimidex)-Placebo
干预措施: Anastrozole (Drug)
Anastrozole-ZD1839
Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)
干预措施: Gefitinib (Drug)
结局指标
主要结局
Time to progression
时间窗: Duration of study
To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer
次要结局
- Overall survival(Duration of Study)
- Safety(Duration of Study)
- Objective response rate(Duration of Study)
- Overall clinical benefit rate(Duration of Study)
- Pharmacokinetic variables(Duration of Study)
- Biomarker objectives(Duration of Study)