A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
NCT ID: NCT05912933
Last Updated: 2025-06-13
Study Results
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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COMPLETED
733 participants
OBSERVATIONAL
2024-08-19
2024-08-30
Brief Summary
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This study is seeking participants:
* treated with the study medicine Palbociclib
* having any breast cancer records in same month as the index date (the first prescription date)
* having prescription records of palbociclib from 20 December 2016 to 29 February 2024
The study design is a cohort study. This study design uses de-identified patient data from a hospital based electronic medical record and claim database in Japan.
One of the important side effects of taking Palbociclib is neutropenia (decreased count of neutrophils - a type of white blood cell). In this study, the relationship between neutropenia caused by Palbociclib and hepatic impairment was studied after it was released to the market. To do that, the study gathered details of breast cancer patients newly treated with Palbociclib from 23 hospitals and 10 medical institutes across Japan.
The below patient details were collected:
* dose of Palbociclib
* other medicines prescribed for cancer
* age
* gender
* past information on cancer treatments
* laboratory findings at baseline
The result was based on the neutrophil count collected from the laboratory data. Around 1300 patients newly treated with Palbociclib for breast cancer was calculated by the medical information database network (MID-NET) in 6 years from 15 December 2017.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort
New users of palbociclib for inoperable or recurrent breast cancer divided into 4 groups based on severity levels of hepatic impairment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Having any breast cancer records in same month as the first prescription date.
* Having laboratory tests and visit records (SS-MIX2) on or before 180 days prior to the first prescription date
* Having SS-MIX2 hospital-visit records within 180 days before the first prescription date
Exclusion Criteria
* Having any records of anti-HER2 medication
0 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer New York
New York, New York, United States
Countries
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Other Identifiers
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A5481116
Identifier Type: -
Identifier Source: org_study_id
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