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

NCT07223476 | Completed

• 1 other identifier: CLEE011APT03
• Study Type: observational
• Target: 1,926
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Cyclin-dependent Kinase 4/6 Inhibitor; Real-world

Outcome Measures

Primary Outcomes (4)

• Number of Patients Treated With a CDKI Between November 2018 and May 2023

  Up to approximately 4 years and 6 months

• Median Treatment Duration

  Up to approximately 4 years and 6 months

• Median Time to Next Treatment (TTNT)

  TTNT was calculated considering the time between the start of one treatment line and the start of the next treatment line.

  Up to approximately 4 years and 6 months

• Number of Patients With Dose Reductions by Treatment Length per Line of Treatment

  Patients were categorized as having 0, 1, or 2 dose reductions over 0-6 months, 7-12 months, and 12 months or more of treatment.

  Up to approximately 4 years and 6 months

Study Arms (3)

Ribociclib Treatment Group

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

Palbociclib Treatment Group

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

Abemaciclib Treatment Group

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: March 29, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)