Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Expression of progesterone
研究概览
简要总结
Background: Identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment.
Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER and progesterone- PR), some patients become hormone resistant. In order to identify a possible profile associated to hormonal resistance, some biomarkers have been assessed after short period primary hormone therapy (HT).
Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and anastrozole in short term hormone therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Basic Science
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive breast cancer post-menopausal women
- •Estrogen and/or progesterone receptor positive
排除标准
- •Patients with endocrine disease
- •Hormone therapy users or those who had been pregnant in the last 12 months before the diagnosis
- •Patients with a negative expression for estrogen and/or progesterone receptors
- •Women with a history of thromboembolism
- •Patients who had previously undergone any treatment for breast cancer
研究组 & 干预措施
Placebo
Placebo
干预措施: Anastrozole (Drug)
Tamoxifen
Tamoxifen 20 mg day 26 days
干预措施: Anastrozole (Drug)
Anastrozole
Anastrozole 1mg 26 days
干预措施: Anastrozole (Drug)
结局指标
主要结局
Expression of progesterone
时间窗: end of the study (june 2008)
次要结局
- Expression of Ki-67(end of the study (june 2008))