A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.

Study Overview
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Brief Summary
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CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies. The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC). Female patients aged 18 years old or more presenting the following conditions will be selected for the study: HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease Diagnosis of ABC/MBC between 01 January 2016 and 01 July 2021 Treatment with CDK4/6 inhibitor Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.

Official Title
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Treatment Patterns And Clinical Outcomes Among Patients Receiving CDK4/6 Inhibitors Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In A Canadian Real World Setting

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease Diagnosed with ABC/MBC between 01 Jan 2016 and 01 July 2021 Treatment with CDK4/6 inhibitor Exclusion Criteria: Patient does not have ABC/MBC Patient has indicated HR- or HER2+ status Patient received a CDK4/6i as part of a clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC.<br>Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With HR+/HER2-ABC/MBC receiving palbociclib combination treatment | To characterize real world treatment patterns among patients with HR+/HER2-ABC/MBC receiving palbociclib combination treatment (non-steroidal AI (NSAI) [letrozole or anastrozole], or fulvestrant). | 01 Jan 2016 through 01 Oct 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with pre-CDK4/6i treatment patterns and sequencing in ABC/MBC | To explore treatment patterns and sequencing before the introduction of CDK4/6 inhibitor. | 01 Jan 2016 through 01 Oct 2021 | 
| Number of patients with post-CDK4/6i treatment patterns and sequencing in ABC/MBC | To explore treatment patterns and sequencing after introduction of CDK4/6 inhibitors | 01 Jan 2016 through 01 Oct 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic breast cancer, advanced breast cancer, HR+/HER2-