NCT00093002已完成2 期
A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).
适应症
干预措施
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
- 179
- 试验地点
- 1
- 主要终点
- Anti-proliferative effect after 4 weeks of treatment.
研究概览
简要总结
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women defined as women who have stopped having menstrual periods
- •Written informed consent to participate in the trial
- •Biopsy confirmation of invasive breast cancer
- •Evidence of hormone sensitivity
- •Willingness to undergo biopsies
排除标准
- •Any previous treatment for breast cancer
- •Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
- •Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
- •The presence of more than one primary tumor
- •History of hypersensitivity to castor oil
- •History of known bleeding disorders
研究组 & 干预措施
1
Experimental
250 mg fulvestrant
干预措施: Fulvestrant (Drug)
2
Experimental
500 mg fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Anti-proliferative effect after 4 weeks of treatment.
次要结局
- Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.
研究者
研究点 (1)
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