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
NCT ID: NCT05153135
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4320 participants
OBSERVATIONAL
2020-05-08
2020-07-31
Brief Summary
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Detailed Description
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Adult women with HR+/HER2- mBC initiated on a CDK4/6 inhibitor were included in the study and were stratified into cohorts based on the first CDK4/6 inhibitor they received (i.e., abemaciclib, palbociclib, or ribociclib), regardless of the line of therapy and menopausal status.
The initiation of the first CDK4/6 inhibitor was defined as the index date. The index treatment was defined as the CDK4/6 inhibitor initiated on the index date (i.e., abemaciclib, palbociclib, or ribociclib).
The 6-month period preceding the index date was considered as the baseline period, and was used to measure patient characteristics.
Outcomes were measured between the index date and 1) the end of the study period (persistence, switch, HRU, costs) OR 2) the end of the index treatment (adherence, dose modification, frequency of monitoring), as relevant. The end of the study period was defined as the earliest occurrence between the end of continuous enrollment and the end of data availability.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Ribociclib
Participants who initiated CDK4/6i therapy
Ribociclib
Participants who initiated CDK4/6i therapy
Palbociclib
Participants who initiated CDK4/6i therapy
Palbociclib
Participants who initiated CDK4/6i therapy
Abemaciclib
Participants who initiated CDK4/6i therapy
Abemaciclib
Participants who initiated CDK4/6i therapy
Interventions
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Ribociclib
Participants who initiated CDK4/6i therapy
Palbociclib
Participants who initiated CDK4/6i therapy
Abemaciclib
Participants who initiated CDK4/6i therapy
Eligibility Criteria
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Inclusion Criteria
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
18 Years
99 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
East Hanover, New Jersey, United States
Countries
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Related Links
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Results for CLEE011AUS65 from the Novartis Clinical Trials Website
Other Identifiers
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CLEE011AUS65
Identifier Type: -
Identifier Source: org_study_id