An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,056
- 试验地点
- 163
- 主要终点
- Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
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
- •Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
- •Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
- •Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤
- •Adequate organ function.
排除标准
- •Participants who have received prior systemic treatment in the advanced or metastatic setting.
- •Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
- •Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
干预措施: Letrozole (Drug)
Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
干预措施: Palbociclib (Drug)
Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole.
干预措施: BGB-43395 (Drug)
Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
干预措施: Ribociclib (Drug)
Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole.
干预措施: Letrozole (Drug)
Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 4 years
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
次要结局
- Progression-Free Survival 2 (PFS2)(Up to approximately 4 years)
- Overall Survival (OS)(Up to approximately 11 years)
- Overall Response Rate (ORR)(Up to approximately 4 years)
- Duration of Response (DOR)(Up to approximately 4 years)
- PFS Determined by Investigator(Up to approximately 4 years)
- Clinical Benefit Rate (CBR)(Up to approximately 4 years)
- Time to Response (TTR)(Up to approximately 4 years)
- Number of Participants with Adverse Events (AEs)(From first dose of study drug up to 30 days after last dose, up to approximately 11 years)
- Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC)-Item Library (IL)454.(Baseline and up to approximately 4 years)