Clinical trial · Observational
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
Longitudinal Evaluation of Early Breast Cancer With Adjuvant Real-World Data in the Post-CDK4/6 Inhibitor Approval Era: Analysis Using Integra PrecisionQ Oncology Database (LEEWARD)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- HR+/HER2- eBC Cohort
- description
- 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 outcomes (7)
- measure
- Percentage of Eligible Population that Received Genetic Testing
- timeFrame
- Baseline, up to approximately 1 year, 7 months
- description
- Testing includes germline mutation testing, Oncotype DX testing, Ki-67 scoring, and other breast cancer specific genetic tests (breast cancer index, Mammaprint, Endopredict, Prosigna).
- measure
- Number and Percentage of Patients by Treatment Regimen
- timeFrame
- Baseline, up to approximately 1 year, 7 months
- description
- Number and percentage of patients by treatment regimen in the neo-adjuvant and adjuvant setting, stratified by patient and provider characteristics, and CDK4/6i eligibility.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion criteria:
* 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:
1. Nodal stage (N) N2 or N3 disease.
2. 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.
3. Node-negative with the following high-risk criteria:
1. Tumor size is T3, T4
2. Tumor size is T2 and Grade 3
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
Exclusion criteria:
* 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.References
Publications (0)
Data not yet available