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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

NCT ID: NCT05153187

Last Updated: 2024-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-31

Study Completion Date

2020-11-26

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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with HR+/HER2- advanced breast cancer

No interventions assigned to this group

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Japan Inc.

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A5481115

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5481115

Identifier Type: -

Identifier Source: org_study_id

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