Clinical trial NCT04916509: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Retrospective Studies
palbociclib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-06-07
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Demographical Characteristics of Participants
timeFrame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
measure: Demographical Characteristics of Participants: Biomarker status
timeFrame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
measure: Clinical Characteristics of Participants: Description of diagnosis
timeFrame: Upon BC diagnosis up to date of index treatment (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
measure: Number of patients receiving adjuvant therapies
timeFrame: Upon diagnosis of BC (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019)
measure: Number of participants receiving treatment for advanced/metastatic BC before and after palbociclib combination use
timeFrame: 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)
measure: Number of participants with dose changes associated with palbociclib use
timeFrame: From 01 January 2015 to 30 September 2019
measure: Number of participants to discontinue treatment associated with palbociclib use
timeFrame: From 01 January 2015 to 30 September 2019
measure: Number of participant receiving supportive therapies while receiving palbociclib combination treatment
timeFrame: From 01 January 2015 to 30 September 2019
measure: Proportion of patients who are progression free at multiple intervals
timeFrame: 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
measure: Objective response rate (ORR)
timeFrame: From date of index treatment up to 57 months
measure: Proportion of patients alive 1 and 2 years post palbociclib combination initiation depending on availability of follow-up data (if available)
timeFrame: From 01 January 2015 to 30 September 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City National Guard Hospital
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City National Guard Hospital Riyahd
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City Riyadh PO BOX 7805
city: Al Ain
country: United Arab Emirates
facility: Tawam
city: Dubai
country: United Arab Emirates
facility: Dubai Hospital
city: Dubai
country: United Arab Emirates
facility: Mediclinic City Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: King Abdul-Aziz Medical City, National Guard Hospital
name: Meteb Al-Foheidi
role: PRINCIPAL_INVESTIGATOR
References: