A Randomized, 2-Arm, Open-Label, Ph-II Study of Abemaciclib Combined With ET w/ or w/o CT With Paclitaxel as 1L in Patients With Unresectable Locally Advanced or Metastatic HR(+)/HER2(-) BC With Aggressive Disease Criteria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 31
- 主要终点
- 12-week overall response rate (ORR)
研究概览
简要总结
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET (letrozole or fulvestrant) in patients with previously untreated, unresectable locally advanced, or metastatic HR positive/HER2 negative breast cancer with aggressive disease criteria.
详细描述
The ABIGAIL study aims to provide consistent evidence that the combination of abemaciclib with ET -consisting of letrozole or fulvestrant-as first-line regimen is non-inferior to the optimal first-line chemotherapy -consisting of weekly paclitaxel-in terms of early ORR after the first 12 weeks of treatment in patients with HR-positive/HER2-negative ABC and at least one feature of aggressive disease associated with poor prognosis.
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
- All
- 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
Interventional Arm (Arm A)
Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular [IM] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter.
干预措施: Abemaciclib (Drug)
Interventional Arm (Arm A)
Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular [IM] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter.
干预措施: Letrozole (Drug)
Interventional Arm (Arm A)
Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular [IM] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter.
干预措施: Fulvestrant (Drug)
Control Arm (Arm B)
Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
12-week overall response rate (ORR)
时间窗: 12 weeks
Complete response (CR) or partial response (PR), during the first 12 weeks of treatment as per blinded independent central review, using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
次要结局
- ORR(Baseline up to 24 months)
- Clinical benefit rate (CBR)(Baseline up to 24 months)
- 12-week progression-free survival (PFS) rate(Baseline up to 12 weeks)
- PFS(Baseline up to 24 months)
- Time to response (TTR)(Baseline up to 24 months)
- Duration of response (DoR)(Baseline up to 24 months)
- Overall survival (OS)(Baseline up to 24 months)
- Maximum tumor shrinkage (MTS)(Baseline up to 24 months)
- Time to first subsequent therapy (TFST)(Baseline up to 24 months)
- Patient-reported global quality of life (QoL)(At the beginning of each cycle up to 36 months after study start.)
- Time to second subsequent therapy (TSST)(Baseline up to 24 months)
- Time to first chemotherapy (TFC)(Baseline up to 24 months)
- Incidence of adverse events (AEs)(Baseline up to 24 months)