Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region

June 1, 2026 updated by: Pfizer

Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region Like Saudi Arabia, UAE and Other GCC Countries: A Retrospective Study (Treasure Study)

retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2- metastatic/locally advanced breast cancer (BC)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 22384
        • King Abdulaziz Medical City National Guard Hospital
      • Riyadh, Saudi Arabia, 11426
        • King Abdulaziz Medical City National Guard Hospital Riyahd
      • Riyadh, Saudi Arabia, 11472
        • King Saud University Medical City Riyadh PO BOX 7805
  • United Arab Emirates
      • Al Ain City, United Arab Emirates
        • Tawam
      • Dubai, United Arab Emirates
        • Dubai Hospital
      • Dubai, United Arab Emirates
        • Mediclinic City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Palbociclib plus an aromatase inhibitor

Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor.

Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.

Aligned with Locally Approved Indication
Drug: Palbociclib plus an aromatase inhibitor
Palbociclib plus an aromatase inhibitor therapy
palbociclib plus fulvestrant

Adult metastatic breast cancer patients who initiated Palbociclib + fulvestrant. Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.

Aligned with Locally Approved Indication
Drug: Palbociclib plus fulvestrant
Palbociclib plus fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographical Characteristics of Participants
Time Frame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Demographical Characteristics of Participants: Biomarker status
Time Frame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Biomarker status - (estrogen receptor [ER], progesterone receptor [PR], HER-2 neu, Ki67, Germline BRCA [gBRCA] testing).
Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Clinical Characteristics of Participants: Description of diagnosis
Time Frame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Description of diagnosis - staging, node status, menopause status, diagnosis for which palbociclib combination was prescribed, sites of metastases, de novo vs. recurrent disease.
Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Number of patients receiving adjuvant therapies
Time Frame: Upon diagnosis of BC (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)
Upon diagnosis of BC (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Number of participants receiving treatment for advanced/metastatic BC before and after palbociclib combination use
Time Frame: Upon diagnosis of metastatic/locally advanced HR+/HER2 BC for a maximum of 4 years approximately (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Treatments and supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis. Duration of treatments. Reasons for regimen changes. Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible reasons for change in treatment. Line of treatment.
Upon diagnosis of metastatic/locally advanced HR+/HER2 BC for a maximum of 4 years approximately (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
Number of participants with dose changes associated with palbociclib use
Time Frame: From 01 January 2015 to 30 September 2019
Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
From 01 January 2015 to 30 September 2019
Number of participants to discontinue treatment associated with palbociclib use
Time Frame: From 01 January 2015 to 30 September 2019
Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
From 01 January 2015 to 30 September 2019
Number of participant receiving supportive therapies while receiving palbociclib combination treatment
Time Frame: From 01 January 2015 to 30 September 2019
Supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis while receiving palbociclib combination treatments. Duration of treatments.
From 01 January 2015 to 30 September 2019
Proportion of patients who are progression free at multiple intervals
Time Frame: From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 57 months
Proportion of progression free survival/time to progression (at intervals per standard of care) (eg. 12, 18 months).
From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 57 months
Objective response rate (ORR)
Time Frame: From date of index treatment up to 57 months
Proportion of objective response rate (at intervals per standard of care).
From date of index treatment up to 57 months
Proportion of patients alive 1 and 2 years post palbociclib combination initiation depending on availability of follow-up data (if available)
Time Frame: From 01 January 2015 to 30 September 2019
From 01 January 2015 to 30 September 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Actual)

December 27, 2022

Study Completion (Actual)

December 27, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481136
  • TREASURE (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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