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)

NCT05912933 | Completed

• 1 other identifier: A5481116
• Study Type: observational
• Target: 733
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With/Without Hepatic Impairment for Grade 4 Neutropenia in New Users of Palbociclib

  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.

  20 Dec 2016 through 29 Feb 2024

Secondary Outcomes (1)

• Number of Participants With/Without Hepatic Impairment for Grade 3-4 Neutropenia in New Users of Palbociclib

  20 Dec 2016 through 29 Feb 2024

Study Arms (1)

Cohort

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

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients treated with Palbociclib

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New York

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 22, 2023
• Study Start: August 19, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)