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

An observational study of Breast Neoplasms, run by Pfizer at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Neoplasms
What is being tested?: Palbociclib plus an aromatase inhibitor and Palbociclib plus fulvestrant
How many people: 258 participants
Where: 7 sitesin 3 countries
Study dates: 13 Sep 2021to 27 Dec 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

Age ≥18 years old.
HR+/HER2- BC diagnosis with confirmed metastatic/locally advanced disease.
Patient initiated on palbociclib (regardless the line of therapy) within the period between 01st January 2015 and 01st March 2019.
Minimum of six months of follow up data since palbociclib initiation.
Received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s).

Who cannot join

Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC.
Patients who were initiated on palbociclib after 01st March 2019.

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Saudi Arabia3 sites

King Abdulaziz Medical City National Guard Hospital
Jeddah, 22384
King Abdulaziz Medical City National Guard Hospital Riyahd
Riyadh, 11426
King Saud University Medical City Riyadh PO BOX 7805
Riyadh, 11472

Other trials in Saudi Arabia

United Arab Emirates3 sites

Tawam
Al Ain City
Dubai Hospital
Dubai
Mediclinic City Hospital
Dubai

Other trials in United Arab Emirates

Qatar1 site

Hamad Medical Corporation
Doha

Other trials in Qatar

About this study

Official title: 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)

Conditions: Breast Neoplasms
Being tested: Palbociclib plus an aromatase inhibitor, Palbociclib plus fulvestrant
Keywords: Retrospective Studies, palbociclib
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Palbociclib plus an aromatase inhibitorDrug
Palbociclib plus an aromatase inhibitor therapy
Palbociclib plus fulvestrantDrug
Palbociclib plus fulvestrant

Study groups in NCT04916509
Study group	Role	What they receive
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 Receives: Drug: Palbociclib plus an aromatase inhibitor
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 Receives: Drug: Palbociclib plus fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

Demographical Characteristics of Participants
Measured: 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
Biomarker status - (estrogen receptor [ER], progesterone receptor [PR], HER-2 neu, Ki67, Germline BRCA [gBRCA] testing).
Measured: 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
Description of diagnosis - staging, node status, menopause status, diagnosis for which palbociclib combination was prescribed, sites of metastases, de novo vs. recurrent disease.
Measured: 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
Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)
Measured: 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
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.
Measured: 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
Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
Measured: From 01 January 2015 to 30 September 2019
Number of participants to discontinue treatment associated with palbociclib use
Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
Measured: From 01 January 2015 to 30 September 2019
Number of participant receiving supportive therapies while receiving palbociclib combination treatment
Supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis while receiving palbociclib combination treatments. Duration of treatments.
Measured: From 01 January 2015 to 30 September 2019
Proportion of patients who are progression free at multiple intervals
Proportion of progression free survival/time to progression (at intervals per standard of care) (eg. 12, 18 months).
Measured: 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)
Proportion of objective response rate (at intervals per standard of care).
Measured: 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)
Measured: From 01 January 2015 to 30 September 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 202127 Dec 2022

First posted7 Jun 2021
Study start13 Sep 2021
Primary completion27 Dec 2022
Study completion27 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04916509
Sponsor's protocol ID: A5481136
Other IDs: TREASURE
Status last verified: Nov 2025
First submitted: 19 May 2021
Last updated: 2 Jun 2026
Results posted: No
Data monitoring committee: No
Individual data sharing: No: 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.

Publications

Dawoud E, Calaud F, Fadlelseid AA, Abdelhafeez N, Kullab S, Latif MF, Omara M, Tirmazy S, Hashiesh A, AlJabban A, Dawood S, Al-Foheidi M. 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: A Retrospective Study (TREASURE Study). Int J Breast Cancer. 2026 Sep 22;2026:3477817. doi: 10.1155/ijbc/3477817. eCollection 2026.
PubMed 42780561

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04916509
Acronym / sponsor ID: A5481136
Conditions: Breast Neoplasms
Keywords: Retrospective Studies, palbociclib
Study type: Observational
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 13 Sep 2021 (actual)
Primary completion: 27 Dec 2022 (actual)
Study completion: 27 Dec 2022 (actual)
First posted: 7 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Palbociclib plus an aromatase inhibitor	–	Drug: Palbociclib plus an aromatase inhibitorAdult 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
palbociclib plus fulvestrant	–	Drug: Palbociclib plus fulvestrantAdult 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (5 listed)

Age ≥18 years old.
HR+/HER2- BC diagnosis with confirmed metastatic/locally advanced disease.
Patient initiated on palbociclib (regardless the line of therapy) within the period between 01st January 2015 and 01st March 2019.
Minimum of six months of follow up data since palbociclib initiation.
Received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s).

Key exclusion criteria (2 listed)

Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC.
Patients who were initiated on palbociclib after 01st March 2019.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Palbociclib plus an aromatase inhibitorPalbociclib plus an aromatase inhibitor therapy	Drug	Palbociclib plus an aromatase inhibitor
Palbociclib plus fulvestrantPalbociclib plus fulvestrant	Drug	palbociclib plus fulvestrant

Primary outcome

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)
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).
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.
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)
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.
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.
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.
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.
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).
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).
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Derived from this study: PubMed 42780561Dawoud E, Calaud F, Fadlelseid AA, Abdelhafeez N, Kullab S, Latif MF, Omara M, Tirmazy S, Hashiesh A, AlJabban A, Dawood S, Al-Foheidi M. 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: A Retrospective Study (TREASURE Study). Int J Breast Cancer. 2026 Sep 22;2026:3477817. doi: 10.1155/ijbc/3477817. eCollection 2026.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Pfizer at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Saudi Arabia, United Arab Emirates, Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04916509, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.