Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan

Study Overview
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Brief Summary
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This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.

Official Title
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Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Palbociclib
* Drug: Endocrine therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of HR+/HER2- ABC Age of 20 years or older at diagnosis of ABC Patients that received palbociclib plus ET in the first line or second line Patients who meet the criteria regarding the medical record below: Patients with any medical records (regardless of palbociclib use) for more than 6 months from palbociclib initiation OR Patients with any medical records for less than 6 months from palbociclib initiation AND who had specific events (death, disease progression, or treatment discontinuation of palbociclib due to adverse events) in the available records Exclusion Criteria: Patients who received chemotherapy as first line treatment. Patients who have previously participated or are participating in any interventional clinical trials that include investigational or marketed products. (Interventional clinical trials for early breast cancer and later line after palbociclib will be acceptable, Besides, patients participating in other investigator-initiated research or noninterventional studies can be included as long as their standard of care is not altered by the study.)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Palbociclib|Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC|
|Drug: Endocrine therapy|Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC |  | 15 December 2017 to 31 August 2023 | 
| rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC |  | 15 December 2017 to 31 August 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC |  | 15 December 2017 to 31 August 2023 | 
| Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC |  | 15 December 2017 to 31 August 2023 | 
| Landmark OS (defined from treatment initiation of first line to death) when palbociclib plus ET were used as second line treatment for HR+/HER2- ABC |  | 15 December 2017 to 31 August 2023 | 
| Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC |  | 15 December 2017 to 31 August 2023 | 
| TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET |  | 15 December 2017 to 31 August 2023 | 
| Time to chemotherapy (TTC: defined as the time from treatment initiation of first or second line for HR+/HER2- ABC to first use of chemotherapy) |  | 15 December 2017 to 31 August 2023 | 
| Real-world objective response rate (rwORR) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC |  | 15 December 2017 to 31 August 2023 | 
| Demographic of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan |  | 15 December 2017 to 31 August 2023 | 
| Clinical characteristics of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan |  | 15 December 2017 to 31 August 2023 | 
| Treatment patterns of palbociclib plus ET in routine clinical practice in Japan |  | 15 December 2017 to 31 August 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retrospective, Multicenter, Observational, Effectiveness, Real-world progression free survival, Palbociclib, Endocrine therapy, Japan, Hormone receptor positive/ human epidermal growth factor negative (HR+/HER2-), Advanced Breast Cancer, First-line therapy, Second-Line therapy