NCT05851014招募中3 期
A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 52
- 主要终点
- Investigator-assessed PFS based on RECIST v1.1
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old;
- •Have a pathologically-confirmed diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer;
- •No previous systematic antitumor therapy for locally advanced or metastatic breast cancer;
- •Eastern Cooperative Oncology Group [ECOG] 0-1;
- •Have adequate organ and marrow function;
- •Agree to sign the informed consent;
排除标准
- •Systematic treatment with any other CDK4/6 inhibitor；
- •Subjects with known allergy to GB491 or any component of Letrozole；
- •Confirmed diagnosis of HER2 positive disease;
- •Known uncontrolled, or symptomatic central nervous system metastases;
- •Had major surgery (or is expected to require major surgery during the study period), chemotherapy, radiation, any investigational drug, or other antitumor therapy within 4 weeks prior to randomization;
- •Have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer;
- •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, or ventricular arrhythmia which need medical intervention；
- •Known history of HIV infection or HIV seropositivity (including HIV antibody positive at the time of screening)
研究组 & 干预措施
GB491 combined with Letrozole
Experimental
干预措施: GB491 combined with Letrozole (Drug)
Placebo combined with Letrozole
Placebo Comparator
干预措施: Placebo combined with Letrozole (Drug)
结局指标
主要结局
Investigator-assessed PFS based on RECIST v1.1
时间窗: Approximately 60 months
To evaluate progression-free survival (PFS) of GB491 plus Letrozole versus placebo plus Letrozole in HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy (as assessed by the investigator).
次要结局
- DCR(Approximately 60 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(Approximately 60 months)
- BICR-assessed PFS based on RECIST v1.1.(Approximately 60 months)
- OS(Approximately 60 months)
- CBR(Approximately 60 months)
- ORR(Approximately 60 months)
- DOR(Approximately 60 months)
研究者
研究点 (52)
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