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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Palbociclib plus an aromatase inhibitor
* Drug: Palbociclib plus fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC. Patients who were initiated on palbociclib after 01st March 2019.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Palbociclib plus an aromatase inhibitor<br>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<br>* Palbociclib plus an aromatase inhibitor therapy<br>|
| palbociclib plus fulvestrant<br>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<br>* Palbociclib plus fulvestrant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retrospective Studies, palbociclib