Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by Pfizer.
NCT05912933 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 1,342 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,342 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2024-08-30 |
What the finished NCT05912933 record still lists
NCT05912933 is an observational study that tracks outcomes without assigning an intervention. Its 1,342 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT05912933 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06731608 · 1,344 participants · NA
OsteoPorotic fracTure preventION System (OPTIONS) Research Study
- NCT06972056 · 1,335 participants · Phase 4
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
- NCT06318169 · 1,350 participants · Phase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
- NCT06605404 · 1,350 participants
Pan-tumor MRD Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI