A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors

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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07647042
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC) patients who became eligible for treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) in the real-world setting after the FDA approval of ribociclib treatment for eBC. The study used data abstracted from structured and unstructured patient electronic health records from sites available in the Integra Connect PrecisionQ database (secondary data use).

Key Dates

Start date
Mar 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
750 participants (actual)

Arms

  • Arm: HR+/HER2- eBC Cohort
    Adult HR+/HER2- eBC patients eligible for treatment with CDK4/6i (ribociclib and abemaciclib) since the approval of ribociclib in the real-world setting.

Primary Outcome Measure

Percentage of Eligible Population that Received Genetic Testing [ Time Frame: Baseline, up to approximately 1 year, 7 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
NovartisEast HanoverNew Jersey07936-

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