A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 115
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis
- •Participants must have 1 or more of the following:
- •A high grade tumor in tissue
- •Negative progesterone receptor (PR) status
- •Have cancer that has spread to the liver
- •Have a treatment-free interval (TFI) <36 months
- •Participants must have HR+, HER2- breast cancer
- •Participants must have adequate organ function
排除标准
- •Participants must not have cancer that has spread to other organs that has severely affected their function
- •Participants must not have cancer that has spread to the brain that is unstable or untreated
- •Participants must not have received endocrine therapy in the metastatic setting
- •Participants must not have known active infection
- •Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment
- •Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 & 6 inhibitor or everolimus
研究组 & 干预措施
Abemaciclib + NSAI
Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
干预措施: Abemaciclib (Drug)
Abemaciclib + NSAI
Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
干预措施: Nonsteroidal Aromatase Inhibitor (NSAI) (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
PFS
Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
时间窗: Baseline to Objective Disease Progression (Estimated up to 26 Months)
ORR
次要结局
- Duration of Response (DoR)(Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months))
- Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)(Baseline to Objective Disease Progression (Estimated up to 26 Months))
- Clinical Benefit Rate (CBR): Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months(Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months))
- Time to Response (TTR)(Baseline to Date of CR or PR (Estimated up to 26 Months))