Clinical trial · Observational
Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
NCT05153135CI-TRIAL-00055605completedClinicalTrials.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)
The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
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 |
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Ribociclib
- description
- Participants who initiated CDK4/6i therapy
- interventionNames
- Drug: Ribociclib
- 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
- 99 Years
Show eligibility criteria text
Inclusion Criteria: \- Evidence of treatment with a CDK4/6 inhibitor regardless of the line of therapy. The initiation of the first CDK4/6 inhibitor was defined as the index date, and the first CDK4/6 inhibitor initiated was defined as the index treatment * BC diagnosis: Two diagnosis codes of BC (International Classification of Diseases, 9th Revision, Clinical Modification \[ICD-9-CM\]: 174.xx and International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\]: C50.xx \[excluding C50.x2 - male BC\]) on two medical service claims separated by at least 30 days * Metastatic disease diagnosis: At least two medical claims for a secondary neoplasm (ICD-9-CM codes: 196.xx-197.xx, 198.xx, ICD-10-CM codes: C77.xx, C78.xx, C79.xx) on separate dates, with the first one occurring no more than 30 days before the first diagnosis for BC * HR+/HER2-: At least one prescription fill or administration of an ET (anastrazole, exemestane, ethinyl estradiol, fulvestrant, fluoxymesterone, letrozole, megestrol acetate, tamoxifen, or toremifene), HR+/HER2- therapy (everolimus), or CDK4/6 inhibitor (i.e., abemaciclib, palbociclib, or ribociclib) at any time following the diagnosis of BC, and no claims for treatments indicated for HER2+ BC, including trastuzumab, lapatinib, afatinib, pertuzumab, or ado-trastuzumab, at any time in the data period * Women of at least 18 years of age as of the index date * At least 6 months of continuous health plan coverage prior to and at least 1 month of continuous health plan coverage after the index date Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.