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

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05153135
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Participants who initiated CDK4/6i therapy
  • Palbociclib — DRUG
    Participants who initiated CDK4/6i therapy
  • Abemaciclib — DRUG
    Participants who initiated CDK4/6i therapy

Study Details

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.

Key Dates

Start date
May 8, 2020
Status verified
Dec 2021
Primary completion
Jul 31, 2020
Completion
Jul 31, 2020

Study Design

Enrollment
4,320 participants (actual)

Arms

  • Arm: Ribociclib
    Participants who initiated CDK4/6i therapy
  • Arm: Palbociclib
    Participants who initiated CDK4/6i therapy
  • Arm: Abemaciclib
    Participants who initiated CDK4/6i therapy

Primary Outcome Measure

Number of inpatient (IP) admissions [ Time Frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteEast HanoverNew Jersey07936-

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