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

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: Breast Neoplasms
• Intervention / Treatment: Drug: Palbociclib plus an aromatase inhibitor; Drug: Palbociclib plus fulvestrant

• Study Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

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		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).	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.	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)	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.	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.	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.	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.	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).	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).	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)		From 01 January 2015 to 30 September 2019

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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: Retrospective Studies; palbociclib
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant; palbociclib
• 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.