Fulvestrant With or Without AZD6244, a Mitogen-Activated Protein Kinase Kinase (MEK) ½ Inhibitor, in Advanced Stage Breast Cancer Progressing After Aromatase Inhibitor: A Randomized Placebo-Controlled Double-Blind Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 17
- 主要终点
- Disease control (sum of complete response, partial response, and stable disease) at 24 weeks or more according to RECIST 1.1 criteria
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without AZD6244 in treating patients with advanced breast cancer.
PURPOSE: This randomized phase II trial is studying how well fulvestrant works with or without AZD6244 in treating patients with advanced breast cancer that progressed after aromatase inhibitor therapy.
详细描述
OBJECTIVES:
Primary
- To assess the efficacy of fulvestrant with versus without MEK inhibitor AZD6244 in patients with advanced stage, endocrine-sensitive breast cancer that progressed after aromatase inhibitor therapy.
Secondary
- To assess the safety and tolerability of this regimen in these patients.
- To examine other outcome parameters.
- To develop a virtual tissue bank for future translational research.
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)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: Fulvestrant / AZD6244
Fulvestrant 500mg i.m. day 1, 15, day 1 of cycle 2, then every 28 +/- 3 days AZD6244 75 mg p.o. bid
干预措施: fulvestrant (Drug)
Arm A: Fulvestrant / AZD6244
Fulvestrant 500mg i.m. day 1, 15, day 1 of cycle 2, then every 28 +/- 3 days AZD6244 75 mg p.o. bid
干预措施: selumetinib (Drug)
Arm B: Fulvestrant / Placebo
Fulvestrant 500mg i.m. day 1, 15, day 1 of cycle 2, then every 28 +/- 3 days Placebo 3 caps p.o. bid (same appearance as AZD6244)
干预措施: fulvestrant (Drug)
结局指标
主要结局
Disease control (sum of complete response, partial response, and stable disease) at 24 weeks or more according to RECIST 1.1 criteria
时间窗: at 24 weeks or more according to RECIST 1.1 criteria
次要结局
- Duration of response(will be calculated from the time that measurement criteria are met for the first time until documented tumor progression.)
- Overall survival(Overall survival will be calculated from registration until death)
- Adverse events(according to NCI CTCAE v 4.0)
- Overall response(according to RECIST 1.1)
- Progression-free survival(will be calculated from randomization until documented tumor progression or death, whichever occurs first.)
- Time to treatment failure(will be calculated from randomization to discontinuation of all trial treatment due to any reason)