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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05153187
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-31
• Primary Completion: 2020-11-26
• Study Completion: 2020-11-26
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1170

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 )

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Exclusion Criteria

-Received a prescription of anti-HER2 therapy (Trastuzumab, Trastuzumab emtansine, Pertuzumab, and Lapatinib tosilate hydrate)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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)
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)
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)
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Pfizer Japan Inc.; 🇯🇵 Tokyo, Japan