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Gulf study reveals Real-World use of palbociclib for advanced breast cancer

NCT ID NCT04916509

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed study looked at medical records of 258 adults in Saudi Arabia, UAE, and other Gulf countries who received palbociclib (a targeted cancer pill) combined with hormone therapy for advanced HR+/HER2- breast cancer. Researchers aimed to describe patient characteristics, treatment patterns, and outcomes like how long the cancer was controlled. Since this is a retrospective study, it does not test a new treatment but provides real-world insights into how palbociclib is used in this region.

What this could mean

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

Active substance
Palbociclib (a targeted cancer drug) combined with either an aromatase inhibitor or fulvestrant
What this could lead to
If successful, this study could help doctors in the Gulf region better understand how palbociclib is used in real-world practice and what outcomes patients experience.
What could go wrong
This is a retrospective study that only looks back at existing data, so it cannot prove cause and effect. Results may not apply to other regions or newer treatment approaches.

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

258 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2022

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

Data will be abstracted from the medical records of all eligible patients across 17 - 35 selected sites from Arabian Gulf Region countries. The observational period for patients is the 57 month-period prior to the study index date. During this period, patients who initiated treatment with palbociclib between 01st January 2015 and 01st March 2019 will be considered eligible for participation in the study. Sites from diverse health care settings

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: 1. Age ≥18 years old. 2. HR+/HER2- BC diagnosis with confirmed metastatic/locally advanced disease. 3. Patient initiated on palbociclib (regardless the line of therapy) within the period between 01st January 2015 and 01st March 2019. 4. Minimum of six months of follow up data since palbociclib initiation. 5. Received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s). Exclusion Criteria: 1. Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC. 2. Patients who were initiated on palbociclib after 01st March 2019.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast neoplasms

Contacts and locations

Locations

  • Dubai Hospital

    Dubai, United Arab Emirates

  • Hamad Medical Corporation

    Doha, Qatar

  • King Abdulaziz Medical City National Guard Hospital

    Jeddah, 22384, Saudi Arabia

  • King Abdulaziz Medical City National Guard Hospital Riyahd

    Riyadh, 11426, Saudi Arabia

  • King Saud University Medical City Riyadh PO BOX 7805

    Riyadh, 11472, Saudi Arabia

  • Mediclinic City Hospital

    Dubai, United Arab Emirates

  • Tawam

    Al Ain City, United Arab Emirates

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