A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
Completed
Conditions studied: Breast Cancer
In brief
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 facts
- Study ID
- NCT07647042
- Run by
- Novartis Pharmaceuticals
- People needed
- 750
- Starts
- 2026-03-31
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with HR+/HER2- breast cancer.
- No evidence of distant metastatic spread.
- Underwent primary breast cancer surgery (mastectomy/lumpectomy) during the study period.
- Initiated adjuvant ET within 12 months of surgery date and after September 17, 2024, to the period up to 3 months prior to the data cutoff date.
- Had at least one visit during the baseline period and at least one visit one day after the index date.
- Patients included must have met one of the following conditions at the time of diagnosis or surgery:
- Nodal stage (N) N2 or N3 disease.
- N1 any anatomic tumor size (T), including micrometastatic patients except T0 N1mi and T1 N1mi; For T0 N1mi and T1 N1mi patients with Grade 3 disease alone will be selected.
- Node-negative with the following high-risk criteria:
- Tumor size is T3, T4
- Tumor size is T2 and Grade 3
- Tumor size is T2 with Grade 2 and either Ki-67 score ≥ 20% or genomic high risk based on Oncotype Dx/Mammaprint/Endopredict/Prosigna
You may not qualify if…
- Use of any prior CDK4/6i before the index date.
- Missing T or N values for both clinical and surgical stage.
- Diagnosis of cancer other than breast cancer.
- Evidence of participation in a clinical trial at any time during the study observation period.
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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