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

October 29, 2025 updated by: Novartis Pharmaceuticals

Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for HR+/HER2- Advanced/Metastatic 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1926

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Treated With a CDKI Between November 2018 and May 2023
Time Frame: Up to approximately 4 years and 6 months
Up to approximately 4 years and 6 months
Median Treatment Duration
Time Frame: Up to approximately 4 years and 6 months
Up to approximately 4 years and 6 months
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.
Up to approximately 4 years and 6 months
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.
Up to approximately 4 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

October 29, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Estimated)

October 31, 2025

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEE011APT03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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