A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 57
- 主要终点
- Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
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
- None
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
- •Participants must be females of post-menopausal status with HR+, HER2- breast cancer that has spread to internal organs
- •Participants must have had at least one endocrine therapy
- •Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study
- •If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study
排除标准
- •Participants must not have breast cancer that has spread to the brain if untreated and with symptoms
- •Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy
- •Participants must not have certain active infections including HIV or hepatitis
- •Participants must not be pregnant or breastfeeding
- •Participants must not have certain types of cancers or certain previous cancer treatments
- •Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants
研究组 & 干预措施
Abemaciclib + Fulvestrant
150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.
干预措施: Abemaciclib (Drug)
Abemaciclib + Fulvestrant
150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.
干预措施: Fulvestrant (Drug)
Standard Chemotherapy
Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
干预措施: Standard Chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
时间窗: Randomization to Measured Progressive Disease (Up to 12 Months)
ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to the corresponding treatment arm \[intent-to-treat (ITT) population\], based on investigator-assessed tumor responses.CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking in reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Confirmations of CR and PR are not required.
次要结局
- Time to Response (TTR)(First Dose to Date of CR or PR (Up to 12 Months))
- Progression Free Survival (PFS)(First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months))
- Progression Free Survival 2 (PFS 2)(Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months))
- Duration of Response (DoR)(Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months))