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)

Trial Title: 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)

NCT ID: NCT05709158

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: 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

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Other

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.

Criteria for eligibility:

Study pop:
Breast cancer patients treated with Palbociclib

Sampling method: Probability Sample
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. 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

Gender: All

Minimum age: 0 Years

Maximum age: N/A

Healthy volunteers: No

Start date: March 1, 2024

Completion date: April 30, 2024

Lead sponsor:
Agency: Pfizer
Agency class: Industry

Source: Pfizer

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05709158
https://pmiform.com/clinical-trial-info-request?StudyID=A5481093