A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decrease… (NCT05912933) | Clinical Trial Compass
CompletedNot Applicable
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)
United States1,342 participantsStarted 2024-08-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. - Having laboratory tests and visit records (SS-MIX2) on or before 180 days prior to the first prescription date- Having SS-MIX2 hospital-visit records within 180 days before the first prescription dateExclusion Criteria:- Having an absolute neutrophil count (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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study specifically looked at whether liver problems affect the risk of severe neutropenia in people taking palbociclib, do I have any degree of hepatic impairment that might put me at higher risk for Grade 4 neutropenia if I take palbociclib?
2This study has already completed — has my doctor seen the findings, and do the results change how they would monitor my bone marrow function or adjust my palbociclib dose if I were to take it?
3Grade 4 neutropenia is a serious drop in infection-fighting white blood cells — how would my care team watch for this, and what would happen to my treatment if I developed it while on palbociclib?
4Since this was an observational study measuring real-world patterns rather than a randomized trial testing a new treatment, does it give my doctor enough information to feel confident about how my liver health might affect my safety on palbociclib?
5Are there standard treatment options my doctor would consider before or alongside palbociclib, especially given what this study found about the connection between liver function and severe bone marrow side effects?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With/Without Hepatic Impairment for Grade 4 Neutropenia in New Users of Palbociclib