Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

Study Overview
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Brief Summary
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A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices

Official Title
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Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as 1st Line Therapy in Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed HR+/HER2- status after MBC diagnosis. Received palbociclib + AI or AI as first-line therapy Exclusion Criteria: Evidence of prior treatment with other CDK4/6I, AI, tamoxifen, raloxifene, toremifene, or Fulvestrant for MBC First structured activity greater than 90 days after MBC diagnostic date Treatment with a CDK4/6 inhibitor 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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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 + an aromatase inhibitor<br>Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database. | Drug: Palbociclib + an aromatase inhibitor<br>* Palbociclib + an aromatase inhibitor therapy<br>|
| Aromatase inhibitor<br>Adult metastatic breast cancer patients who initiated an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database. | Drug: Aromatase inhibitor<br>* Aromatase inhibitor therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study | From date of index treatment until date of death from any cause or end of study, whichever came first, assessed up to 68 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world progression free survival (rwPFS) | rwPFS2 is the number of months from start of palbociclib + AI or AI alone to disease progression (based on clinical assessment or by radiographic scan/tissue biopsy) on the 2nd line of therapy or death from any cause, whichever occurred first | From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 68 months | 
| Real-world tumor responses (rwTR) | Real-world best responses are assessed based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment after 1 month of index treatment initiation | From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 68 months | 
| Initial dose of palbociclib | Describe initial dose of palbociclib treatment pattern | From date of index treatment up to 68 months | 
| Time to dose adjustment |  | From date of index treatment to dose adjustment, assessed up to 68 months | 
| Duration of treatment |  | From date of index treatment to end of the treatment, death, or end of study, whichever came first, assessed up to 68 months | 
| Time to subsequent treatments |  | From date of index treatment to subsequent treatment, death, or end of study, whichever came first, assessed up to 68 months | 
| Time to chemotherapy |  | From date of index treatment to subsequent chemotherapy, death, or end of study, whichever came first, assessed up to 68 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cyclin-dependent kinase 4/6i (CDK4/6i)