A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark

Study Overview
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Brief Summary
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The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment

Official Title
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A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with breast cancer (International Statistical Classification of Diseases and Related Health Problems, 10th Revision [ICD-10]: ICD-10 code for patients with breast cancer [DC50]) A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer Initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 January 2017 and 31 December 2020 Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI/progression leading to initiation of palbociclib+fulvestrant Exclusion Criteria: There are no exclusion criteria for this study

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) of patients receiving palbociclib in combination with aromatase inhibitor (AI) |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 | 
| Time on Treatment (ToT) of patients receiving palbociclib in combination with aromatase inhibitor (AI) |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of the patients |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 | 
| Disease specific characteristics |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 | 
| PFS and ToT of palbociclib in combination with fulvestrant |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 | 
| Overall survival (OS) of patients receiving palbociclib in combination with AI |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 (with censoring by 01 May 2022 and also reported after 6, 12 and 24 months of palbociclib treatment [landmark]) | 
| OS of patients receiving palbociclib in combination with fulvestrant |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 (with censoring by 01 May 2022 and also reported after 6, 12 and 24 months [landmark]) | 
| First subsequent post-palbociclib treatment upon progression |  | At initiation of treatment with palbociclib as either 1st or 2nd line treatment between 01 Jan 2017 and 31 Dec 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Cancer, HR+/ HER2-