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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)

NCT05912933 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 733

Last updated 2025-06-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912933 on ClinicalTrials.gov