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NCT05912933 · ClinicalTrials.gov registry record
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)
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 1,342
- Enrollment target
NCT05912933 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 1,342 participants.
The verdict
NCT05912933 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 1,342 participants
- Enrollment target
Study 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 2024The 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 baselineThe 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,342 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2024-08-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05912933
The ClinicalTrials.gov registry entry for NCT05912933 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,342 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT05912933 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05912933 about?
NCT05912933 is a clinical study titled "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)". 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 dat...
What is the current status of trial NCT05912933?
This trial is currently completed. The enrollment target is 1,342 participants. The study started on 2024-08-19. Estimated completion is 2024-08-30.
Who is sponsoring clinical trial NCT05912933?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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