TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS IN BRAZIL RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 121
- 试验地点
- 28
- 主要终点
- Proportion of patients who are progression free following clinical outcomes in overall population and defined subgroups for patients who had a potential follow-up of 6 months after palbociclib combination treatment initiation
研究概览
简要总结
The objective of this study is to describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Brazil.
详细描述
The primary objective of this real world study is to describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use.
Primary Objectives
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To describe the demographic and clinical characteristics of patients who have received palbociclib combination treatments in line with locally approved indications.
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To describe adjuvant therapies received for their treatment of early or locally advanced breast cancer (Stages 0-IIIa).
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To describe treatments received in the advanced/metastatic setting, before and after palbociclib combination use.
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To describe dosing and dose changes, interruptions, delays, and discontinuations associated with palbociclib use in clinical practice.
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To describe supportive therapies received by patients while receiving palbociclib combination treatments.
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To determine the following outcome in overall population and defined subgroups for patients who had received palbociclib combination treatment for at least 6 months:
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Progression-free survival;
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Objective response rate (ORR);
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Proportion of patients alive.
Exploratory Objectives
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
- •HR+/HER2- breast cancer diagnosis with confirmed ABC/MBC
- •Received palbociclib as a first line therapy
- •No prior or current enrolment in an interventional clinical trial for ABC/MBC
- •Have a potential follow-up period of 6 months following the index date (30 days after first palbociclib prescription: palbociclib with fulvestrant and/or palbociclib with letrozole/aromatase inhibitor).
排除标准
- •Patients who were enrolled to receive fulvestrant but already received previous therapies
结局指标
主要结局
Proportion of patients who are progression free following clinical outcomes in overall population and defined subgroups for patients who had a potential follow-up of 6 months after palbociclib combination treatment initiation
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe dosing associated with palbociclib use in clinical practice
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe delays associated with palbociclib use in clinical practice
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe discontinuations associated with palbociclib use in clinical practice
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Demographical characteristics of patients who have received palbociclib combination treatments in line with locally approved indications
时间窗: 30 days after prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Adjuvant treatments received for subset of patients previously diagnosed with non-metastatic breast cancer who progressed to locally advanced (stage IIIB/C) or metastatic (stage IV) breast cancer.
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe supportive therapies received by patients while receiving palbociclib combination treatments
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe treatments received in the advanced/metastatic setting before palbociclib combination use
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe dose changes associated with palbociclib use in clinical practice
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Real world Objective response rate (ORR) following clinical outcomes in overall population and defined subgroups for patients who had a potential follow-up of 6 months after palbociclib combination treatment initiation
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Proportion of patients alive following clinical outcomes in overall population and defined subgroups for patients who had a potential follow-up of 6 months after palbociclib combination treatment initiation
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe treatments received in the advanced/metastatic setting after palbociclib combination use
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
Describe interruptions associated with palbociclib use in clinical practice
时间窗: 30 days after the physician first prescribed palbociclib + partner therapy until completion of this study in 2022.
30 days after the physician first prescribed palbociclib + partner therapy following the approval of the indication in Brazil . From when palbociclib + letrozole was available Feb 1, 2018 in Brazil and the physician initiated a patient on palbociclib+ letrozole until completion of this study in 2022.
次要结局
未报告次要终点