Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib in Combination With Fulvestrant (PB+FUL) In The US Community Oncology Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Time to Chemotherapy
研究概览
简要总结
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of HR+/HER2- mBC
- •Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date
- •Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes
排除标准
- •Enrollment in an interventional clinical trial during the study period
- •Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting
- •Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.
结局指标
主要结局
Time to Chemotherapy
时间窗: From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Real-World Duration of Treatment (rwDOT)
时间窗: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Time to Next Treatment (TTNT) From Index Treatment
时间窗: From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Percentage of Participants With Provider Documented Disease Progression
时间窗: From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure.
Real-World Time to Tumor Progression (rwTTP)
时间窗: From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis.
Number of Participants According to Reasons for Treatment Discontinuation
时间窗: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure.
Real-World Progression-Free Survival (rwPFS)
时间窗: From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis.
Overall Survival (OS)
时间窗: From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
次要结局
未报告次要终点
