A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Real-World Progression-Free Survival (rwPFS)
研究概览
简要总结
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed HR+/HER2- recurrent or metastatic breast cancer.
- •Presence of a pathogenic PIK3CA mutation confirmed by tissue or plasma-based NGS/PCR testing.
- •Availability of traceable electronic medical records, imaging, laboratory, and follow-up data at baseline.
- •Initiated treatment with "Inavolisib + Endocrine Therapy" with or without a CDK4/6 inhibitor in real-world clinical practice, with complete and traceable regimen information.
- •Provision of informed consent for this non-interventional study (if required by the center's ethics committee).
排除标准
- •Concurrent participation in any interventional clinical trial at enrollment.
- •Presence of another active malignancy requiring concurrent systemic therapy, or missing core data preventing outcome assessment.
- •Any condition (psychiatric, social, geographical) that would preclude adequate follow-up, as judged by the investigator.
研究组 & 干预措施
Inavolisib+CDK4/6i+ET
干预措施: Inavolisib in Combination With ET+CDK4/6i (Drug)
inavolisib+ET
干预措施: Inavolisib in Combination With ET (Drug)
结局指标
主要结局
Real-World Progression-Free Survival (rwPFS)
时间窗: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years
Time from the index date (first prescription of inavolisib) to the first recorded disease progression (based on radiological or clinical assessment) or death from any cause, whichever occurs first.
次要结局
- Stratified rwPFS for Cohort A and Cohort B(From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years)
- Number of Participants With Adverse Events (AEs)(Up to approximately 36 months)
- Real-world Duration of Response (rwDoR)(From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months))
研究者
xuliang
Attending Physician
Peking University Cancer Hospital & Institute