Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal (PORTRAIT)
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Jersey
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East Hanover, New Jersey, United States, 07936
- Novartis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Ribociclib Treatment Group
HR+/HER2- a/mBC patients with at least 1 month of ribociclib treatment.
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Palbociclib Treatment Group
HR+/HER2- a/mBC patients with at least 1 month of palbociclib treatment.
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Abemaciclib Treatment Group
HR+/HER2- a/mBC patients with at least 1 month of abemaciclib treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Patients Treated With a CDKI Between November 2018 and May 2023
Time Frame: Up to approximately 4 years and 6 months
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Up to approximately 4 years and 6 months
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Median Treatment Duration
Time Frame: Up to approximately 4 years and 6 months
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Up to approximately 4 years and 6 months
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Median Time to Next Treatment (TTNT)
Time Frame: Up to approximately 4 years and 6 months
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TTNT was calculated considering the time between the start of one treatment line and the start of the next treatment line.
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Up to approximately 4 years and 6 months
|
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Number of Patients With Dose Reductions by Treatment Length per Line of Treatment
Time Frame: Up to approximately 4 years and 6 months
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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.
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Up to approximately 4 years and 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLEE011APT03
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