Clinical trial · Observational
Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer
Efficacy and Safety of Adjuvant CDK4/6 Inhibitors in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Breast Cancer: a Real-world Study
NCT07180056CI-TRIAL-00097480recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDK4/6 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adjuvant CDK4/6 inhibitor
- description
- CDK4/6 inhibitors are drugs that block cell division in cancer cells. They are used with hormonal therapy for hormone receptor-positive breast cancer and may improve survival.
- interventionNames
- Drug: CDK4/6 inhibitor
Primary outcomes (1)
- measure
- Invasive Disease-free Survival (iDFS)
- timeFrame
- From the date of surgery until time of event up to 2 years.
- description
- Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Secondary outcomes (3)
- measure
- Disease-free Survival (DFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 and older * Patients with pathologically confirmed breast cancer without distant metastasis or local recurrence * HR+/HER2- * ECOG 0-3 * Subjects meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors Exclusion Criteria: * During pregnancy or lactation * Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
References
Publications (0)
Data not yet available
No reference posted for this study.