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Breast cancer drug IBRANCE® under Real-World watch in korea

NCT ID NCT03445637

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study looked at how safe and effective the drug IBRANCE® is for women with advanced breast cancer when used in everyday medical practice. Researchers tracked 552 women in Korea for side effects and how well the drug worked. The goal was to gather real-world information to support the drug's approved use.

What this could mean

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

Active substance
palbociclib (IBRANCE®)
What this could lead to
If successful, this study could confirm that IBRANCE® is safe and effective in real-world use for advanced breast cancer patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only included Korean women, so findings may not apply to other groups.

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

552 people

The number who actually took part.

Started

Feb 2018

Finished

Jul 2025

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

All participants enrolled should meet the usual prescribing criteria for IBRANCE® as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.

Ages

18 years and older

Sex

Female participants only

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 * Women of ≥18 years of age with proven diagnosis of advanced/metastatic breast cancer (locoregionally recurrent or metastatic disease). * Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice). * Human Epidermal Growth Factor Receptor 2 -(HER2-) breast cancer based on local laboratory results (test as per local practice or local guidelines) * Patients must be appropriate candidates for hormone therapy. * Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * During the post marketing surveillance (PMS) period, patients who initially administer IBRANCE® Exclusion Criteria * Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients. * Pregnant women

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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 neoplasm

Contacts and locations

Locations

  • Pfizer

    Seoul, South Korea

More trials for these conditions

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