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

Completed

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT05361655

Run by

Pfizer

People needed

2888

Starts

2021-09-01

Expected to finish

2021-09-01

Last updated by the study team

2024-06-07

Who can join

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

You may qualify if…

• Confirmed HR+/HER2- status after MBC diagnosis.
• Received palbociclib + AI or AI as first-line therapy

You may not qualify if…

• 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

Where it is running

• 10017 — New York, New York, United States

Full record on ClinicalTrials.gov

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