Clinical trial · Observational
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study
NCT05795335CI-TRIAL-00066478recruitingClinicalTrials.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)
This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced 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
- Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.
- interventionNames
- Drug: CDK4/6 inhibitor
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
- description
- PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 and older * Confirmed diagnosis of hormone receptor-positive breast cancer. * Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy. * Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease. * ECOG 0-2 * Adequate organ function Exclusion Criteria: * Subjects disable to swallow pills. * History of immunodeficiency disease
References
Publications (0)
Data not yet available
No reference posted for this study.