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
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT04916509
- Lead Sponsor
- Pfizer
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 258
- 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).
- Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC.
- Patients who were initiated on palbociclib after 01st March 2019.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Palbociclib plus an aromatase inhibitor 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 palbociclib plus fulvestrant 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
- Primary Outcome Measures
Name Time Method 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) Biomarker status - (estrogen receptor \[ER\], progesterone receptor \[PR\], HER-2 neu, Ki67, Germline BRCA \[gBRCA\] testing).
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 Proportion of progression free survival/time to progression (at intervals per standard of care) (eg. 12, 18 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 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) Description of diagnosis - staging, node status, menopause status, diagnosis for which palbociclib combination was prescribed, sites of metastases, de novo vs. recurrent disease.
Number of participants with dose changes associated with palbociclib use From 01 January 2015 to 30 September 2019 Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
Number of participants to discontinue treatment associated with palbociclib use From 01 January 2015 to 30 September 2019 Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.
Number of participant receiving supportive therapies while receiving palbociclib combination treatment From 01 January 2015 to 30 September 2019 Supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis while receiving palbociclib combination treatments. Duration of treatments.
Number of patients receiving adjuvant therapies Upon diagnosis of BC (from data collected and observed retrospectively between 01 January 2015 and 01 March 2019) Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)
Objective response rate (ORR) From date of index treatment up to 57 months Proportion of objective response rate (at intervals per standard of care).
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) 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
King Abdulaziz Medical City National Guard Hospital Riyahd
🇸🇦Riyadh, Saudi Arabia
Dubai Hospital
🇦🇪Dubai, United Arab Emirates
King Saud University Medical City Riyadh PO BOX 7805
🇸🇦Riyadh, Saudi Arabia
Tawam
🇦🇪Al Ain, United Arab Emirates
Hamad Medical Corporation
🇶🇦Doha, Qatar
King Abdulaziz Medical City National Guard Hospital
🇸🇦Jeddah, Saudi Arabia
Mediclinic City Hospital
🇦🇪Dubai, United Arab Emirates