A Partially Blind Phase III Randomised Trial of Faslodex +/- Concomitant Arimidex Compared With Exemestane in Post-menopausal Women With ER+ or PR+ Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal AIs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 698
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival of postmenopausal women with estrogen receptor- and/or progesterone receptor-positive, locally advanced or metastatic breast cancer that relapsed or progressed during prior treatment with nonsteroidal aromatase inhibitors treated with fulvestrant with vs without anastrozole vs exemestane alone.
Secondary
- Compare the objective complete response (CR) and partial response (PR) rate and duration of response in patients treated with these regimens.
- Compare the clinical benefit (i.e., 6-month CR, PR, and stable disease) rate and duration of clinical benefit in patients treated with these regimens.
- Compare time to treatment failure in patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Arimidex vs Arimidex-placebo component is double-blinded. Faslodex is not blinded Exemestane is not blinded
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Faslodex + placebo
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
干预措施: Anastrozole (Drug)
Faslodex + placebo
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
干预措施: Fulvestrant (Drug)
Faslodex + Arimidex
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
干预措施: Anastrozole (Drug)
Faslodex + Arimidex
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
干预措施: Fulvestrant (Drug)
Exemestane
exemestane orally once a day
干预措施: Exemestane (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Assessed up to 190 months
defined as time from randomisation to progression of existing disease, new sites of disease, second primary cancer if change in systemic treatment was necessary, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Objective Response Rate(From start of treatment, every 3 months to treatment discontinuation and/or up to 190 months)
- Duration of Response(Assessed up to 190 months)
- Clinical Benefit Rate(Assessed up to 190 months)
- Duration of Clinical Benefit(Assessed up to 190 months)
- Time to Treatment Failure(To discontinuation of protocol treatment for any reason, or progression of disease assessed up to 190 months)
- Overall Survival(To death assessed up to 190 months.)
- Tolerability of Treatment(From start of treatment to discontinuation of treatment/progression assessed up to 190 months)