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Clinical trial

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)

ID
Name
A5481136
Description
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)
Trial arms
Trial start
2021-09-13
Estimated PCD
2022-12-27
Trial end
2022-12-27
Status
Completed
Treatment
Palbociclib plus an aromatase inhibitor
Palbociclib plus an aromatase inhibitor therapy
Arms:
Palbociclib plus an aromatase inhibitor
Palbociclib plus fulvestrant
Palbociclib plus fulvestrant
Arms:
palbociclib plus fulvestrant
Size
258
Primary endpoint
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
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
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
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
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
From 01 January 2015 to 30 September 2019
Number of participants to discontinue treatment associated with palbociclib use
From 01 January 2015 to 30 September 2019
Number of participant receiving supportive therapies while receiving palbociclib combination treatment
From 01 January 2015 to 30 September 2019
Proportion of patients who are progression free at multiple intervals
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)
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
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 258, 'type': 'ACTUAL'}}
Updated at
2023-06-06

1 organization

2 products

1 indication

Organization
Pfizer
Product
Palbociclib
Indication
Breast Neoplasms
Product
Palbociclib plus fulvestrant