Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan

Study Overview
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Brief Summary
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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.

Official Title
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Descriptive Analyses of Clinical Characteristics and Treatment Patterns of Breast Cancer Patients Initiating Palbociclib (Ibrance(Registered)) Treatment in Japan by Using MDV Database

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ) Exclusion Criteria: -Received a prescription of anti-HER2 therapy (Trastuzumab, Trastuzumab emtansine, Pertuzumab, and Lapatinib tosilate hydrate)
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with HR+/HER2- advanced breast cancer<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and clinical characteristics of ABC patients at the initiation of treatment with palbociclib |  | 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 |  | 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 |  | 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 palbociclib treatment, 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 subsequent therapy after end of palbociclib treatment |  | 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 |  | 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 |  | 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 |  | Date of first prescription to the date of last patient record or to the end of data collection (Oct 2022) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced breast cancer, Hormone receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)