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

• Sponsor: Pfizer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05132101
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Anticipated Duration (Months): 7.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Patients who received Palbociclib as first line therapy in MBC setting

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: 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
• Actual Study Start Date: Dec 20, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jul 30, 2022

Outcome Measures

Primary Outcome Measures

1. Total treatment duration and cycle for Palbociclib [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

1. Assessment on dose modification of Palbociclib as first line of therapy in BC patients in real-world setting. [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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Local Country Office	Seoul		Korea, Republic of

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05132101
• Other Study ID Numbers: A5481167; Palbociclib HIRA
• First Posted: Nov 24, 2021
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Hormone receptor positive (HR+); Human Epidermal Growth Factor Receptor 2 Negative (HER2-); Metastatic Breast Cancer (MBC)
• Additional relevant MeSH terms: Breast Neoplasms; Palbociclib

Study Results

No Results Posted as of Jul 1, 2022