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

Pfizer258 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

258

Conditions

Breast Neoplasms

Interventions

Palbociclib plus an aromatase inhibitorDRUG

Palbociclib plus an aromatase inhibitor therapy

Palbociclib plus fulvestrantDRUG

Palbociclib plus fulvestrant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Hamad Medical Corporation

Doha, Qatar

King Abdulaziz Medical City National Guard Hospital

Jeddah, Saudi Arabia

King Abdulaziz Medical City National Guard Hospital Riyahd

Riyadh, Saudi Arabia

King Saud University Medical City Riyadh PO BOX 7805

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

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

Biomarker status - (estrogen receptor \[ER\], progesterone receptor \[PR\], HER-2 neu, Ki67, Germline BRCA \[gBRCA\] testing).

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)

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.

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)

Number of patients receiving adjuvant therapies

Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)

Time frame: 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.

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)

Data from ClinicalTrials.gov

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