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OpenTrials
Completed

NCT Number: NCT07223476

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Up to approximately 4 years and 6 months

  2. Median Treatment Duration

    Time frame: Up to approximately 4 years and 6 months

  3. Median Time to Next Treatment (TTNT)

    Time frame: Up to approximately 4 years and 6 months

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

  4. Number of Patients With Dose Reductions by Treatment Length per Line of Treatment

    Time frame: Up to approximately 4 years and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for HR+/HER2- Advanced/Metastatic Breast Cancer in Portugal

Acronym: PORTRAIT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2025
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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