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)

January 24, 2023 updated by: Pfizer

Evaluation of Risk Factors Associated With Myelosuppression (Grade 4 Neutropenia) in Breast Cancer Patients Treated With Palbociclib in the Post-marketing Setting: Nested Case-control Study Using the Medical Information Database Network (MID-NET) Database

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Breast cancer patients treated with Palbociclib

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case: G4 neutropenia occurs after palbociclib initiation
Grade 4 neutropenia occurs after initiation of palbociclib Note that: Case patients are categorized as control before incurring grade 4 neutropenia
Control: G4 neutropenia does not occur after palbociclib initiation
Grade 4 neutropenia does not occur after initiation of palbociclib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Risk Factors for Grade 4 Neutropenia in Users of Palbociclib
Time Frame: 01 Jun 2017 through 29 Feb 2024
Grade 4 neutropenia, as the outcome of this study, will be defined as an absolute neutrophil count (ANC) of less than 0.5 × 109 cells/L or less than 500 cells/mL during the "on-treatment" period.
01 Jun 2017 through 29 Feb 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Risk Factors for Grade 4 Neutropenia in New Users of Palbociclib
Time Frame: 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 × 109 cells/L or less than 500 cells/mL during the "on-treatment" period.
20 Dec 2016 through 29 Feb 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2024

Primary Completion (ANTICIPATED)

April 30, 2024

Study Completion (ANTICIPATED)

April 30, 2024

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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