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.
Closest Location
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.
Condition
Breast Cancer
Sex
Male or Female
Age