Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal (PORTRAIT)

Novartis

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07223476

CLEE011APT03

Details and patient eligibility

About

Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.

This study used secondary data from the IQVIA database that collects data from hospital drug consumption. The study included 16 public hospitals across Portugal, for which data on consumption of drugs used in hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) a/mBC treatment was available. Patient selection was based on a set of criteria considering all patients with treatments in the a/mBC setting with use of at least one CDKI from November 2018 to May 2023.

Enrollment: 1,926 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients of all ages.
• Patients with at least one CDKI consumption from November 2018 to May 2023.
• Patients with consumptions in Gynecology and Oncology specialties.

Exclusion criteria

• Consumption patterns of target drugs that are not compatible with any known a/mBC treatment regimen.
• Patients in early stages of breast cancer.

Trial design

1,926 participants in 3 patient groups

Ribociclib Treatment Group

Description:

HR+/HER2- a/mBC patients with at least 1 month of ribociclib treatment.

Palbociclib Treatment Group

Description:

HR+/HER2- a/mBC patients with at least 1 month of palbociclib treatment.

Abemaciclib Treatment Group

Description:

HR+/HER2- a/mBC patients with at least 1 month of abemaciclib treatment.