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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153187
• Other study ID #: A5481115
• Status: Completed
• Start date: August 31, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1170
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Japan	Pfizer Japan Inc.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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