Descriptive Analyses of Clinical Characteristics and Treatment Patterns of Breast Cancer Patients Initiating Palbociclib (Ibrance(Registered)) Treatment in Japan by Using MDV Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,170
- 试验地点
- 2
- 主要终点
- Treatment patterns of subsequent therapy after end of palbociclib treatment, including line of therapy and type of treatment
研究概览
简要总结
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database.
The primary objective of this study is to describe patient demographics, treatment patterns and treatment duration of palbociclib, and subsequent treatment patterns and treatment duration after palbociclib-based therapy among ABC patients in Japan The secondary objective of the study is to describe patient demographics, treatment patterns of ABC patients and treatment duration of endocrine therapy, and subsequent treatment patterns and treatment duration after endocrine therapy among ABC patients in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer based on International statistical classification of diseases and related health problems 10th revision (International Statistical Classification of Diseases and Related Health Problems [ICD-10]) (C50.xx)
- •Received at least one prescription of endocrine therapy drugs
- •Diagnosis of secondary malignant neoplasm based on ICD-10 (C77.x, C78.x, C79.x )
排除标准
- •Received a prescription of anti-HER2 therapy (Trastuzumab, Trastuzumab emtansine, Pertuzumab, and Lapatinib tosilate hydrate)
研究组 & 干预措施
Patients with HR+/HER2- advanced breast cancer
结局指标
主要结局
Treatment patterns of subsequent therapy after end of palbociclib treatment, including line of therapy and type of treatment
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Changes in treatment pattern before and after the launch of palbociclib, the revision of clinical guideline in Japan
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Demographic and clinical characteristics of ABC patients at the initiation of treatment with palbociclib
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Treatment patterns of palbociclib, including line of therapy and type of endocrine therapy combined with palbociclib, and initial dosage
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Time to treatment failure (TTF) of palbociclib in combination with endocrine therapy by the line of therapy
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
TTF of subsequent therapy after end of palbociclib treatment
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Use of antibiotics and/or granulocyte-colony stimulating factor (G-CSF) during treatment with palbociclib
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Frequency of blood tests during treatment with palbociclib
时间窗: Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022)
Percentage of Participants According to Number of Blood Tests at 1 to 4 Weeks From Palbociclib Treatment Initiation
时间窗: Anytime between 1 to 4 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study
Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 1 to 4 weeks after administration of palbociclib is reported in this outcome measure.
Percentage of Participants According to Number of Blood Tests at 5 to 8 Weeks From Palbociclib Treatment Initiation
时间窗: Anytime between 5 to 8 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study
Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 5 to 8 weeks after administration of palbociclib is reported in this outcome measure.
Percentage of Participants According to Number of Blood Tests at 9 to 12 Weeks From Palbociclib Treatment Initiation
时间窗: Anytime between 9 to 12 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study
Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 9 to 12 weeks after administration of palbociclib is reported in this outcome measure.
Percentage of Participants According to Number of Blood Tests at 13 to 16 Weeks From Palbociclib Treatment Initiation
时间窗: Anytime between 13 to 16 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study
Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 13 to 16 weeks after administration of palbociclib is reported in this outcome measure.
Percentage of Participants According to Number of Blood Tests at 17 to 20 Weeks From Palbociclib Treatment Initiation
时间窗: Anytime between 17 to 20 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study
Percentage of participants according to number of blood tests (0, 1, 2, 3, 4 and \>=5) at 17 to 20 weeks after administration of palbociclib is reported in this outcome measure.
Time to Treatment Failure of Palbociclib
时间窗: From start of palbociclib treatment until end of palbociclib treatment or censoring date (maximum up to 42.5 months); available data observed retrospectively over approximately 22 months in this study
Time to treatment failure of palbociclib was defined as time from the date of first palbociclib prescription to the date of lost to follow-up or to the date of the next line of therapy, defined as the end of palbociclib treatment. Time to treatment failure of palbociclib was censored at participant disenrollment or end of study period.
次要结局
- Demographic and clinical characteristics of ABC patients at the initiation of treatment for ABC(Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022))
- Treatment patterns of each line of therapy for ABC patients(Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022))
- Treatment patterns of subsequent therapy after end of endocrine therapy for ABC patients, including line of therapy and type of treatment(Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022))
- TTF of endocrine therapy for ABC patients(Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022))
- TTF of subsequent therapy after end of endocrine therapy for ABC patients(Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022))
- Use of antibiotics and/or G-CSF during treatment with endocrine therapy for ABC(Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022))
- Mean Palbociclib Daily Dose(From start of palbociclib treatment until end of palbociclib treatment or end of study period (maximum up to 42.5 months); available data observed retrospectively over approximately 22 months in this study)
- Number of Participants According to Regimen of First Subsequent Therapy After End of Palbociclib(From first subsequent therapy until end of study period (maximum up to 38.1 months); available data observed retrospectively over approximately 22 months in this study)
- Time to Treatment Failure of Subsequent Therapy After End of Palbociclib(From start of first subsequent therapy until date of lost to follow-up or date of next line of therapy or censoring date (maximum up to 38.1 months); available data observed retrospectively over approximately 22 months in this study)