A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 30
- 主要终点
- Real-world Progression-free Survival (rwPFS)
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
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
- •Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy
- •Participants must receive the treatment of inavolisib for the first time
- •PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay [Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)] by testing of blood or tumor tissue prior to the initiation of inavolisib
排除标准
- •Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant
- •Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling
- •At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study
研究组 & 干预措施
Inavolisib
Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib.
干预措施: Fulvestrant (Drug)
Inavolisib
Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib.
干预措施: Inavolisib (Drug)
Inavolisib
Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib.
干预措施: Palbociclib (Drug)
结局指标
主要结局
Real-world Progression-free Survival (rwPFS)
时间窗: From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months)
次要结局
- Total Dose of Inavolisib Received(Up to approximately 36 months)
- Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation(Up to approximately 36 months)
- Number of Participants With Adverse Events (AEs)(Up to approximately 36 months)
- Real-world Time to Progression (rwTTP)(From index date to first occurrence of PD (up to approximately 36 months))
- Number of Participants With Real-world Tumor Response (rwTR) to the Treatment(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))
- Real-world Time-to-treatment Discontinuation (rwTTD)(From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months))
- Real-world Time to Next Treatment (rwTTNT)(From index date to new anti-cancer therapy (up to approximately 36 months))
- Real-world Time to Chemotherapy (rwTTC)(From index date to date of chemotherapy initiation (up to approximately 36 months))
- Treatment Duration of Inavolisib(Up to approximately 36 months)