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

Pfizer

Status: Completed

Conditions: Metastatic Breast Cancer

Treatments: Drug: Palbociclib + an aromatase inhibitor; Drug: Aromatase inhibitor

Study type: Observational

Funder types: Industry

Identifiers

NCT05361655

A5481151

Details and patient eligibility

About

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.

Enrollment: 2,888 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,888 participants in 2 patient groups

Palbociclib + an aromatase inhibitor

Description:

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.

Treatment:

Drug: Palbociclib + an aromatase inhibitor

Aromatase inhibitor

Description:

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.

Treatment:

Drug: Aromatase inhibitor