Breast CancerPORTRAITNCT07223476
Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 1,926 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2024to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- 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.
Who cannot join
- Consumption patterns of target drugs that are not compatible with any known a/mBC treatment regimen.
- Patients in early stages of breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Keywords
- Cyclin-dependent Kinase 4/6 Inhibitor, Real-world
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Treated With a CDKI Between November 2018 and May 2023
Measured: Up to approximately 4 years and 6 months
Median Treatment Duration
Measured: 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.
Measured: 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.
Measured: Up to approximately 4 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start29 Mar 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223476
- Sponsor's protocol ID
- CLEE011APT03
- Acronym
- PORTRAIT
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2025
- Last updated
- 31 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for HR+/HER2- Advanced/Metastatic Breast Cancer in Portugal
- ClinicalTrials.gov ID
- NCT07223476
- Acronym / sponsor ID
- PORTRAIT / CLEE011APT03
- Conditions
- Breast Cancer
- Keywords
- Cyclin-dependent Kinase 4/6 Inhibitor, Real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,926 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Consumption patterns of target drugs that are not compatible with any known a/mBC treatment regimen.
- Patients in early stages of breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients Treated With a CDKI Between November 2018 and May 2023
Time frame: Up to approximately 4 years and 6 months
Median Treatment Duration
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Treated With a CDKI Between November 2018 and May 2023 (time frame: Up to approximately 4 years and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.