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 CohortAdult 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | - |
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