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Ibrance under the microscope: Real-World data on advanced breast cancer treatment

NCT ID NCT06962969

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This completed study examined the safety and effectiveness of Ibrance (palbociclib) in women with advanced or metastatic breast cancer using a large real-world database. Researchers looked at side effects and how well the drug worked in everyday practice. The study included adult women with hormone receptor-positive, HER2-negative advanced breast cancer who had received at least one prescription of Ibrance.

What this could mean

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

Active substance
Ibrance (palbociclib)
What this could lead to
If successful, this study could confirm that Ibrance is safe and effective in everyday practice for women with advanced breast cancer.
What could go wrong
This is a very small study (only 1 participant) using existing database records, so results may not apply to all patients. It is observational, not a controlled trial.

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 person

The number who actually took part.

Started

Jun 2025

Finished

Oct 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

Study participants will be patients diagnosed with HR(+)/HER2(-) advanced/metastatic breast cancer between August 29, 2015 and September 30, 2023 who meet the general prescribing criteria for Palbociclib in South Korea according to the national product manual, and who meet the following inclusion and exclusion criteria, as determined by data from one year prior to the Ibrance approval date

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 Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * Adult women (≥ 18 years of age) with at least one visit with a breast cancer ICD10 diagnosis code (C50.x) * Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV (distant metastases). * Patients with a laboratory test positive for hormone receptor (HR) and negative for human epithelial growth factor receptor 2 (HER2) before or up to 60 days after advanced/metastatic breast cancer diagnosis date. 1. HR-positive is defined as any positive test for estrogen receptor or progesterone receptor. 2. HER2-negative is defined as any HER2-negative test and the absence of a positive test (immunohistochemistry positive (3+), fluorescence in situ hybridization positive/amplified). * Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer Exclusion Criteria Patients meeting any of the following criteria will not be included in the study: * Breast cancer with HR-negative and HER2-positive on laboratory testing. * More than a 90-day gap between breast cancer diagnosis date and next visit. * Patients who treated as off-label

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced or metastatic 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.