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)

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05912933

Collaborator

(none)

1,300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

1300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Evaluation of Incidence of Myelosuppression (Grade 4 Neutropenia) in Breast Cancer Patients With Mild, Moderate or Severe Hepatic Impairment Treated With Palbociclib Compared to Patients With Reserved Hepatic Function in the Post-marketing Setting: Cohort Study Using the Medical Information Database Network (MID-NET) Database

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cohort New users of palbociclib for inoperable or recurrent breast cancer divided into 4 groups based on severity levels of hepatic impairment

Outcome Measures

Primary Outcome Measures

Number of Participants With/Without Hepatic Impairment for Grade 4 Neutropenia in New Users of Palbociclib [20 Dec 2016 through 29 Feb 2024]
Grade 4 neutropenia, as the outcome of this study, will be defined as an ANC of less than 0.5 × 10^9 cells/L or less than 500 cells/mL during the "on-treatment" period.

Secondary Outcome Measures

Number of Participants With/Without Hepatic Impairment for Grade 3-4 Neutropenia in New Users of Palbociclib [20 Dec 2016 through 29 Feb 2024]
Grade 3-4 neutropenia, as the outcome of this study, will be defined as an ANC of less than 1.0 × 10^9 cells/L or less than 500 cells/mL during the "on-treatment" period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Having prescription records of palbociclib from 15 December 2017 to 29 February 2024.
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 an absolute neutrophil count (ANC) less than the threshold value for grade 4 neutropenia within 30 days of the first prescription of palbociclib
Having any records of anti-HER2 medication