Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.

Study Overview
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Brief Summary
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By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.

Official Title
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Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib in Combination With Fulvestrant (PB+FUL) In The US Community Oncology Setting

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of HR+/HER2- mBC Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes Exclusion Criteria: Enrollment in an interventional clinical trial during the study period Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.
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 |
| --- | --- |
| PAL + FUL<br>Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Demographic Characteristic of Participants |  | Baseline | 
| Baseline Clinical Characteristics of Participants |  | Baseline | 
| Dosing strength distribution of advanced mBC |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Duration of Treatment (DOT) of advanced mBC |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Number of patients with Prior adjuvant treatment of advanced mBC |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Year of treatment initiation of advanced mBC |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Percentage of patients with dosing changes |  | Treatment initiation through end of study (Assessed up to 60 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to chemotherapy |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Reasons for treatment discontinuation |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Real-world duration of therapy (rwDOT) |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Time to next treatment (TTNT) |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Provider-documented progression |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Real-world time to progression (rwTTP) |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Real-world progression-free survival (rwPFS) |  | Treatment initiation through end of study (Assessed up to 60 months) | 
| Overall survival (OS) |  | Treatment initiation through end of study (Assessed up to 60 months) |