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Liver function may predict dangerous side effect in common breast cancer drug

NCT ID NCT05912933

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study looks at whether breast cancer patients with mild, moderate, or severe liver problems face a higher risk of a serious side effect—grade 4 neutropenia (a dangerous drop in infection-fighting white blood cells)—when taking the drug palbociclib. Researchers analyzed medical records from over 1,300 patients across 23 hospitals in Japan. The goal is to understand how liver impairment influences this side effect, which could help doctors tailor treatment and monitoring for these patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
palbociclib
What this could lead to
If it works, this could help doctors better predict and manage severe neutropenia risk in breast cancer patients with liver problems who take palbociclib.
What could go wrong
This is an observational study using existing data, not a controlled trial. Results may not apply to all populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,342 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Breast cancer patients treated with Palbociclib

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Pfizer New York

    New York, New York, 10001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.