Clinical trial · Observational
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
REal-world Patterns of Treatment With CDKi 4/6 for AdVanced BrEast CAncer in PortugaL - REVEAL Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started treatment with cyclin-dependent kinase inhibitors (CDKi) 4/6 (ribociclib or palbociclib) in Portugal. This was a study of medication use patterns, based on information from the hospital pharmacies of the participating centers. Patients who started a CDKi 4/6 (ribociclib or palbociclib) between 1 March 2019 and 31 December 2019 were included and followed through 24 months. A follow-up occurred 6 months after the start of CDKi 4/6 (ribociclib or palbociclib) to quantify the occurrence of dose changes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- CDKi cohort
- description
- Adult women with HR-positive and HER-2-negative advanced breast cancer who started first- or second-line treatment with CDKi 4/6 (ribociclib or palbociclib).
Primary outcomes (22)
- measure
- Mean Age
- timeFrame
- Baseline, defined as start of treatment with CDKi
- measure
- Number of Pre-menopause Patients by CDKi 4/6
- timeFrame
- Baseline, defined as start of treatment with CDKi
- description
- Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
- measure
- Number of Post-menopause Patients by CDKi 4/6
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female. * Aged 18 years or older at the time of starting therapy with CDKi 4/6. * Breast cancer diagnosis. * At least one record of ribociclib or palbociclib donation during the identification period. * Registration of the first supply of ribociclib or palbociclib between 1 March 2019 and 31 December 2019. Exclusion Criteria: * Patients with missing information regarding their date of birth and the date or quantity of the drug dispensed in any assignment were excluded.
References
Publications (0)
Data not yet available