Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

Study Overview
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Brief Summary
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A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.

Detailed Description
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Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.

Official Title
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Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer

Conditions
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Metastatic Breast Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female sex At least 18 years old at MBC diagnosis Diagnosis of MBC at any point in patient history ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC Confirmation of metastatic disease At least 2 document clinical visits Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents HR+/HER2- HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date. Exclusion Criteria: Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), 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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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 |
| --- | --- |
| 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 3 months prior to date of data cutoff in the Flatiron Health Analytic Database. | Drug: Palbociclib + an aromatase inhibitor<br>* Palbociclib + an aromatase inhibitor therapy<br>|
| Palbociclib + Letrozole<br>Adult metastatic breast cancer patients who initiated Palbociclib +Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database. | Drug: Palbociclib + Letrozole<br>* Palbociclib + Letrozole therapy<br>|
| Letrozole<br>Adult metastatic breast cancer patients who initiated Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database. | Drug: Letrozole<br>* Letrozole monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world progression free survival (rwPFS) | Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months | From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months | 

Secondary 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 acuse or date of end of study, whichever came first, assessed up to 52 months | 
| Real-world tumor response (rwTR) | Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment | From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months | 
| Time to next line of therapy | Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months | From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months | 
| Time to first use of chemotherapy | Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months | From date of index treatemnt to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Palbociclib, Real-world data, Retrospective study, Effectiveness