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)

NCT05709158 | Unknown

• 1 other identifier: A5481093
• Study Type: observational
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Safety; data base 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 Risk Factors for Grade 4 Neutropenia in Users of Palbociclib

  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 Outcomes (1)

• Number of Participants With Risk Factors for Grade 4 Neutropenia in New Users of Palbociclib

  20 Dec 2016 through 29 Feb 2024

Study Arms (2)

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

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

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

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

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

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share