Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Aged ≥18 and older
- •Confirmed diagnosis of hormone receptor-positive breast cancer.
- •Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
- •Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
- •Adequate organ function
排除标准
- •Subjects disable to swallow pills.
- •History of immunodeficiency disease
研究组 & 干预措施
Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.
干预措施: CDK4/6 inhibitor (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.
次要结局
- Overall survival(From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years)
- Adverse events(From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years))
研究者
Jinsong Lu
Jinsong Lu, Chief of Breast Surgery Department, RenJi Hospital
RenJi Hospital