NCT05012644

Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone

REAL-WORLD TUMOR RESPONSE OF PALBOCICLIB IN COMBINATION WITH AN AROMATASE INHIBITOR AS FIRST-LINE THERAPY IN PRE/PERIMENOPAUSAL WOMEN WITH METASTATIC BREAST CANCER

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 197 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on or after 01 January 2010 to on or before 30 June 2020. Data will be obtained from structured data fields within an electronic health record (EHR) database and will be supplemented by additional unstructured data collected through a targeted chart review.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib + aromatase inhibitor	Palbociclib + aromatase inhibitor
DRUG	Aromatase inhibitor	Aromatase inhibitor

Timeline

• Start date: 2021-07-16
• Primary completion: 2021-12-09
• Completion: 2021-12-09
• First posted: 2021-08-19
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

1 site across 1 country: United States