Clinical trial NCT05912933: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Safety
database study in Japan
Ibrance
Palbociclib
hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-)
inoperable or recurrent breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 733
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients treated with Palbociclib

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With/Without Hepatic Impairment for Grade 4 Neutropenia in New Users of Palbociclib
timeFrame: 20 Dec 2016 through 29 Feb 2024
Secondary outcomes:
measure: Number of Participants With/Without Hepatic Impairment for Grade 3-4 Neutropenia in New Users of Palbociclib
timeFrame: 20 Dec 2016 through 29 Feb 2024
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer New York
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: