A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Investigator-assessed PFS
研究概览
简要总结
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
- •Age: 18 - 75 years old
- •No prior systemic anti-cancer therapy for advanced HR+ disease.
- •Eastern Cooperative Oncology Group [ECOG] 0-1
排除标准
- •Patients who received prior treatment with any CDK4/6 inhibitor.
- •Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
研究组 & 干预措施
SHR6390, Letrozole or Anastrozole
SHR6390, Letrozole or Anastrozole
干预措施: SHR6390 Tablets (Drug)
SHR6390, Letrozole or Anastrozole
SHR6390, Letrozole or Anastrozole
干预措施: Letrozole or Anastrozole Tablets (Drug)
Placebo, Letrozole or Anastrozole
Placebo, Letrozole or Anastrozole
干预措施: Placebo Tablets (Drug)
Placebo, Letrozole or Anastrozole
Placebo, Letrozole or Anastrozole
干预措施: Letrozole or Anastrozole Tablets (Drug)
结局指标
主要结局
Investigator-assessed PFS
时间窗: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, Up to approximately 24 months.
Investigator-assessed Progression Free Survival
次要结局
- OS(up to 2 years)
- DoR(Up to approximately 24 months)
- CBR(Up to approximately 24 months)
- Progression-free Survival (PFS) per RECIST 1.1(Up to approximately 24 months)
- ORR(Up to approximately 24 months)
- Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0(Up to approximately 24 months)