A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,054
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
研究概览
简要总结
The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment
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
- •Patients with breast cancer (International Statistical Classification of Diseases and Related Health Problems, 10th Revision [ICD-10]: ICD-10 code for patients with breast cancer [DC50])
- •A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer
- •Initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 January 2017 and 31 December 2020
- •Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI/progression leading to initiation of palbociclib+fulvestrant
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
时间窗: From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)
PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. Kaplan-Meier method was used for analysis.
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
时间窗: From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)
ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib.
次要结局
- Number of Participants Who Underwent Surgery(At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))
- Number of Participants According to Type of Adjuvant Treatment(At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))
- Number of Participants According to Type of Metastases(At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))
- Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression(At progression (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))
- Number of Participants According to Number of Metastases(At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))
- Number of Participants With De Novo and Recurrent Metastatic Breast Cancer(At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))
- Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI(From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years))
- Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant(From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years))
- Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant(From start date of study treatment until stop date of treatment (maximum up to 5.2 years))
- OS in Participants Who Received Palbociclib in Combination With Fulvestrant(From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years))
- Number of Participants According to Location of Metastases(At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))
- Median Time From Initial Breast Cancer Diagnosis to Relapse(At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years]))