A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market
NCT ID: NCT07096024
Last Updated: 2025-08-28
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
1772 participants
OBSERVATIONAL
2025-01-21
2025-02-07
Brief Summary
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* compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before palbociclib was out in the market)
* look into the factors that can cause ILD in new users of palbociclib.
This study uses patient data without giving out any personal information of the patient. This data is taken from a hospital-based claims database of the MDV database, that includes data from more than 400 hospitals in Japan.
This study will use data of patients who are:
* diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 30 November 2024.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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New prescription of palbociclib with fulvestrant.
Patients treated with the combination of palbociclib and fulvestrant
palbociclib plus fulvestrant
Patients treated with the combination of palbociclib and fulvestrant
fulvestrant
Patients treated with fulvestrant alone
New prescription of fulvestrant monotherapy before the launch of palbociclib
Patients treated with fulvestrant alone
fulvestrant
Patients treated with fulvestrant alone
Interventions
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palbociclib plus fulvestrant
Patients treated with the combination of palbociclib and fulvestrant
fulvestrant
Patients treated with fulvestrant alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having any breast cancer records with definitive diagnosis in the same month as the first prescription date.
* Having any records in MDV database on or before 6 months prior to the first prescription date (\<= -180 days: first prescription date = 0 day).
* Having any records in MDV database within 6 months prior to the first prescription date (-180 days to 0 day).
Exclusion Criteria
* Having any records of second primary cancer with definitive diagnosis
15 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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A5481117
Identifier Type: -
Identifier Source: org_study_id
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