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

NCT04916509 | Completed

• 2 other identifiers: A5481136TREASURE
• Study Type: observational
• Target: 258
• Locations: 3 countries
• Sites: 7

Brief 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)

Conditions

Breast Neoplasms

Keywords

Retrospective Studies; palbociclib

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

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 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

Interventions

Palbociclib plus an aromatase inhibitor DRUG

Palbociclib plus an aromatase inhibitor therapy

Palbociclib plus an aromatase inhibitor

Palbociclib plus fulvestrant DRUG

Palbociclib plus fulvestrant

palbociclib plus fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Hamad Medical Corporation

Doha, Qatar

Location

King Abdulaziz Medical City National Guard Hospital

Jeddah, 22384, Saudi Arabia

Location

King Abdulaziz Medical City National Guard Hospital Riyahd

Riyadh, 11426, Saudi Arabia

Location

King Saud University Medical City Riyadh PO BOX 7805

Riyadh, 11472, Saudi Arabia

Location

Tawam

Al Ain City, United Arab Emirates

Location

Dubai Hospital

Dubai, United Arab Emirates

Location

Mediclinic City Hospital

Dubai, United Arab Emirates

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 7, 2021
• Study Start: September 13, 2021
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: June 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1); SA (3); AE (3)