Clinical trial · Observational
A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
NCT05141240CI-TRIAL-00055557completedClinicalTrials.gov clinicaltrialsProvenance
- 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 is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims database.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Ribiciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Ribociclib
- description
- Participants who initiated CDK4/6i therapy
- interventionNames
- Drug: Ribiciclib
- label
- Palbociclib
- description
- Participants who initiated CDK4/6i therapy
- interventionNames
- Drug: Palbociclib
- label
- Abemaciclib
- description
- Participants who initiated CDK4/6i therapy
- interventionNames
- Drug: Abemaciclib
Primary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Treated with CDK4/6i from 2015-02-01 to 2019-06-30 * ≥2 claims with a BC diagnosis recorded ≥30 days apart from the index date * ≥2 claims with an mBC diagnosis, with a time interval between the first BC diagnosis date and the first mBC diagnosis date no longer than 30 days * Female patients aged ≥18 years * Continuous health plan enrollment for ≥3 months prior to the index date and ≥3 months post-index date Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.