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

Completed

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT04176354

Run by

Pfizer

People needed

813

Starts

2019-01-25

Expected to finish

2019-09-27

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pfizer — New York, New York, United States

Full record on ClinicalTrials.gov

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