A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP) - Expert Evaluation Committee Assessment
研究概览
简要总结
To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.
排除标准
- •Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer
研究组 & 干预措施
1
干预措施: exemestane (Drug)
2
干预措施: anastrozole (Drug)
结局指标
主要结局
Time to Progression (TTP) - Expert Evaluation Committee Assessment
时间窗: Up to 2008 days of the treatment
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
次要结局
- Time to Progression (TTP) - Investigators Assessment(Up to 2008 days of the treatment)
- Number of Participants With Objective Response - Investigators Assessment(Up to 2008 days of the treatment)
- Number of Participants With Clinical Benefit - Investigator Assessment(Up to 2008 days of the treatment)
- Overall Survival (OS)(Up to 2008 days of the treatment)
- Time to Treatment Failure (TTF)(Up to 2008 days of the treatment)