A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination With Anastrozole, Compared to Anastrozole Alone, in Post Menopausal Women With Hormone Receptor Positive, Endocrine Therapy Naive, Locally Advanced or Metastatic Breast Cancer (MINT).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
研究概览
简要总结
The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients that have locally advanced or metastatic breast cancer. Lesions should not be amenable to surgery or radiation of curative intent
- •Hormone therapy-naive
- •Estimated life expectancy of more than 12 weeks
排除标准
- •Last dose of prior anti-cancer therapy received within 14 days (or longer if required)
- •Any eye injury or corneal surgery within 3 months prior to receiving first dose of study drug.
- •Currently receiving (and unwilling to discontinue) oestrogen replacement therapy. (last dose <7 days prior to randomisation)
研究组 & 干预措施
1
AZD8931 40mg (bd) plus anastrozole 1mg (od)
干预措施: AZD8931 (Drug)
1
AZD8931 40mg (bd) plus anastrozole 1mg (od)
干预措施: anastrozole (Drug)
2
AZD8931 20mg (bd) plus anastrozole 1mg (od)
干预措施: AZD8931 (Drug)
2
AZD8931 20mg (bd) plus anastrozole 1mg (od)
干预措施: anastrozole (Drug)
3
Placebo (bd) plus anastrozole 1mg (od)
干预措施: anastrozole (Drug)
3
Placebo (bd) plus anastrozole 1mg (od)
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
时间窗: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as \>=20% increase in the sum of longest diameters of target lesions and an absolute increase of \>=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.
次要结局
- Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone(Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status)