A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs

Study Overview
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Brief Summary
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The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN). The real-world study is not a research study. It involves real patients who receive medicines prescribed by their doctors in the real world. Metastatic breast cancer is the type which has spread from breast to other organs. HR positive stands for Hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help cancer cells grow. HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to come back or spread to other parts of the body. This study will mainly measure: - duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (Ibrance) in combination with hormone therapy as first line treatment for HR+ HER2- metastatic breast cancer.

Official Title
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Real-World Utilization of Palbociclib as 1L Treatment in Canadian HR+/HER2-women Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Palbociclib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received at least one cycle of palbociclib as first line therapy for metastatic breast cancer between 01 January 2016 and 31 December 2022 Histologically confirmed HR+/HER2- metastatic breast cancer Minimum of 3 months available follow-up on palbociclib Exclusion Criteria: Received a different CDK4/6 inhibitor before palbociclib in the first line Received other systemic therapy, including hormone therapy, 15-60 days prior to initiation of palbociclib Invalid or incomplete records (more specifically, complete duration of treatment on palbociclib, endocrine therapy or LHRH) Death date recorded on or before the date of index date

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 |
| --- | --- |
| First-line patients on Palbociclib<br>Participants taking oral palbociclib as prescribed in first-line treatment | Drug: Palbociclib<br>* Participants taking oral palbociclib as prescribed in first-line treatment.<br>* Other names: Ibrance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the median Duration of Treatment (DoT) |  | Time index of approximately 01 Jan 2016 to 31 March 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment discontinuation at one-year intervals |  | Time index of approximately 01 Jan 2016 to 31 March 2022 | 
| Number of patients starting at initial dose |  | Time index of approximately 01 Jan 2016 to 31 March 2022 | 
| Time to chemotherapy |  | Time index of approximately 01 Jan 2016 to 31 March 2022 | 
| Clinical Characteristics of Patients |  | Time index of approximately 01 Jan 2016 to 31 March 2022 | 
| Demographical Characteristics of Patients |  | Time index of approximately 01 Jan 2016 to 31 March 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic breast cancer (MBC), Human epidermal growth factor receptor 2 negative (HER2-), Hormone receptor positive (HR+), First line, Real world