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NCT05132101 Clinical Trial

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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05132101
Other study ID # A5481167
Secondary ID Palbociclib HIRA
Status Active, not recruiting
Phase
First received
Last updated
Start date December 20, 2021
Est. completion date June 30, 2023

Study information
Verified date April 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Patients who received Palbociclib as first line therapy in MBC setting
Patients who received Palbociclib as first line therapy in MBC setting

Locations
Country Name City State
Korea, Republic of Pfizer Local Country Office Seoul

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
See also
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Completed NCT01942135 - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Phase 3
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
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Terminated NCT04720664 - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer Phase 2

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