Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 813
- 试验地点
- 1
- 主要终点
- Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method
研究概览
简要总结
A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.
详细描述
Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.
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
- •At least 18 years old at MBC diagnosis
- •Diagnosis of MBC at any point in patient history
- •ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC
- •Confirmation of metastatic disease
- •At least 2 document clinical visits
- •Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents
- •HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
- •HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
- •Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.
排除标准
- •Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or Fulvestrant for MBC
- •First structured activity greater than 90 days after MBC diagnostic date
- •Treatment with a CDK4/6 inhibitor as part of a clinical trial
研究组 & 干预措施
Palbociclib + an aromatase inhibitor
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
干预措施: Palbociclib + an aromatase inhibitor (Drug)
Palbociclib + Letrozole
Adult metastatic breast cancer patients who initiated Palbociclib +Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
干预措施: Palbociclib + Letrozole (Drug)
Letrozole
Adult metastatic breast cancer patients who initiated Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
干预措施: Letrozole (Drug)
结局指标
主要结局
Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method
时间窗: From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
次要结局
- Overall Survival (OS): Using Kaplan-Meier Method(From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method(From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Time to First Use of Chemotherapy: Using Kaplan-Meier Method(From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Response Rate(From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Number of Participants With Real World Tumour Response (rwTR)(From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method(From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))