European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies

Study Overview
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Brief Summary
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A retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + AI as first-line therapy among adult patients with HR+/HER2- advanced breast cancer (ABC) in Europe

Official Title
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European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies Assessed in a Real-World Non-Interventional Study (EUCHARIS)

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Palbociclib + aromatase inhibitor
* Drug: Aromatase inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is male or female Has histologically or cytologically confirmed breast cancer diagnosis (HR+/HER2- breast cancer) Has received a diagnosis of locally advanced breast cancer not amenable to curative radiation or surgical cure or of metastatic breast cancer (i.e., advanced breast cancer [ABC]); diagnosis may be de novo (initial diagnosis at ABC stage) or recurrent from earlier-stage disease (initial diagnosis of earlier-stage disease with subsequent progression to advanced disease) Has initiated a required first-line therapy of interest: Palbociclib plus AI as first-line therapy for ABC between September 1, 2016, and July 31, 2020, or AI monotherapy as first-line therapy for ABC between January 1, 2010,, and July 31, 2020 Was aged 18 years or older at the time of diagnosis of ABC Is living or deceased at the time of record abstraction Has a complete medical record, covering treatment for ABC, including any transfer record from other facilities (if applicable) that is available to the abstractor for data abstraction Exclusion Criteria: The patient's first treatment after ABC diagnosis was chemotherapy (including induction chemotherapy) The patient has evidence of other active malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of ABC; patients diagnosed with second primary cancer after ABC diagnosis will not be excluded The patient has evidence of prior treatment with any CDK4/6 inhibitor (i.e. palbociclib, abemaciclib, ribociclib) in the early-stage breast cancer setting or treatment with abemaciclib or ribociclib in the ABC setting The patient has participated in a clinical trial related to treatment of ABC (including after first-line therapy [i.e., palbociclib plus AI or AI monotherapy])

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 + aromatase inhibitor<br>Adult patients with advanced breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between September 1, 2016, and July 31, 2020. | Drug: Palbociclib + aromatase inhibitor<br>* Palbociclib + an aromatase inhibitor therapy<br>* Other names: Palbociclib + an aromatase inhibitor therapy;|
| Aromatase inhibitor<br>Adult patients with advanced breast cancer patients who initiated an aromatase inhibitor as first line therapy between January 1, 2010,, and July 31, 2020 | Drug: Aromatase inhibitor<br>* Aromatase inhibitor monotherapy<br>* Other names: Aromatase inhibitor monotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world progression free survival |  | Time from treatment line start date to clinician assessed date of disease progression, date of death, or date of censoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Time from treatment line start date to clinician assessed date of disease progression, date of death, or date of censoring | 
| Time to first objective tumor response |  | Time from treatment line start date to clinician-assessed first date of objective response or date of censoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palbociclib, breast cancer, Real-world data, CDK4/6, effectiveness