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NCT05709158 · ClinicalTrials.gov registry record
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)
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 4,184
- Enrollment target
NCT05709158 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 4,184 participants.
The verdict
NCT05709158 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 4,184 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,184 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 NCT05709158
The ClinicalTrials.gov registry entry for NCT05709158 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 4,184 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.
NCT05709158 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05709158 about?
NCT05709158 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT05709158?
This trial is currently completed. The enrollment target is 4,184 participants. The study started on 2024-08-19. Estimated completion is 2024-08-30.
Who is sponsoring clinical trial NCT05709158?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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