Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.

Pfizer

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Palbociclib; Drug: Aromatase Inhibitor

Study type: Observational

Funder types: Industry

Identifiers

NCT06086340

A5481182

Henri 3 (Other Identifier)

Details and patient eligibility

About

A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States

Enrollment: 779 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019
• HR+/HER2- molecular subtype at diagnosis
• Initiated 1L systemic therapy with palbociclib + AI or AI alone

Exclusion criteria

• Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.

Trial design

779 participants in 2 patient groups

Palbociclib + AI

Description:

Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare

Treatment:

Drug: Aromatase Inhibitor

Drug: Palbociclib

AI alone

Description:

Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy

Treatment:

Drug: Aromatase Inhibitor