DEMOGRAPHICS, PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH PALBOCICLIB IN A REAL LIFE SETTING IN ISRAEL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 559
- 试验地点
- 1
- 主要终点
- Number of Participants Categorized According to Type of Index Combination Treatment Regimen
研究概览
简要总结
The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel. This study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy.
This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body.
Patients are followed for around 3.5 years.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of metastatic breast cancer, based on the National/MHS cancer registry.
- •Newly diagnosed metastatic breast cancer patients and newly treated with palbociclib within 6 months of diagnosis, in any line of treatment in the metastatic setting.
- •Available data on palbociclib treatment for at least 6 months.
- •Continuous healthcare plan enrolment in MHS for at least one year before index date.
排除标准
- •Patients that initiated HER2 inhibitors.
研究组 & 干预措施
Patients with metastatic, HR+/HER2- breast cancer.
Patients who initiated first or subsequent lines of treatment with palbociclib
干预措施: palbociclib (Drug)
结局指标
主要结局
Number of Participants Categorized According to Type of Index Combination Treatment Regimen
时间窗: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Duration of Index Treatment Per Type of Combination Treatment
时间窗: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment
时间窗: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants categorized according to number of cycles of treatment including less than or equal to (\<=) 6, greater than (\>) 6 to 11, \>11 to 20 and \>20 cycles were reported. Index treatment was palbociclib combination treatment.
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment
时间窗: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment
时间窗: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment.
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment
时间窗: Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment.
Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment.
Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment
时间窗: From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study
Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.
Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment
时间窗: Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
次要结局
未报告次要终点