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

NCT ID: NCT07223476

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1926 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-29

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Cyclin-dependent Kinase 4/6 Inhibitor Real-world

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ribociclib Treatment Group

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

No interventions assigned to this group

Palbociclib Treatment Group

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

No interventions assigned to this group

Abemaciclib Treatment Group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CLEE011APT03

Identifier Type: -

Identifier Source: org_study_id