Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea

April 6, 2023 updated by: Pfizer

Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a 1st Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea

The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national health insurance claims data in South Korea.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

BC patients who were prescribed with Palbociclib in combination with AI for at least 1 cycle during the index period will be selected as the study population.

Description

Inclusion Criteria:

  • Patients who were prescribed with palbociclib in combination with AI for at least 1 cycle during the index period
  • Patients who were diagnosed with BC during the index period

Exclusion Criteria:

  • Male
  • Prescribed with palbociclib during 12-month period preceding the index date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total treatment duration and cycle for Palbociclib
Time Frame: From index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the end date of last palbociclib prescription (maximum of 34.8 months from the index date)
From index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the end date of last palbociclib prescription (maximum of 34.8 months from the index date)

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment on dose modification of Palbociclib as first line of therapy in BC patients in real-world setting.
Time Frame: From the index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the time of reduction or increase in the dose given in the subsequent Palbociclib prescription (up to 30 Sep 2020)
From the index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the time of reduction or increase in the dose given in the subsequent Palbociclib prescription (up to 30 Sep 2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 11, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481167
  • Palbociclib HIRA (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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