A Study to Learn About the Dangers Linked to Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal Bow Sai Klib)

Pfizer

Status

Not yet enrolling

Conditions

Breast Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT05709158

A5481093

Details and patient eligibility

About

The purpose of this study is to explore risk factors for grade 4 neutropenia in users of the study medicine Palbociclib for the potential treatment of Palbociclib.

This study is seeking participants:

treated with the study medicine Palbociclib
having any breast cancer records in same month as the initiation date
having prescription records of palbociclib from 15 December 2017 to 29 February 2024

The study design is a nested case control study. This study design uses de-identified patient data from a hospital based electronic medical record and claim database in Japan. This design was selected since the primary objective is to explore risk factors of Grade 4 neutropenia in users of the study medicine Palbociclib.

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 effect of Palbociclib in decreasing the neutrophil count 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.

Patients who develop grade 4 neutropenia after palbociclib initiation will be matched to controls who do not develop grade 4 neutropenia. A statistical model will be used to explore risk factors of grade 4 neutropenia adjusted for important potential confounding factors.

Enrollment

1,300 estimated patients

Sex

All

Volunteers

No 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.

Exclusion criteria

Having an 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