Real-world Studies of CDK4/6 Inhibitors
A single-center, real-world study evaluated the clinical outcomes and safety of CDK4/6 inhibitors combined with endocrine therapy in HR+/HER2- advanced breast cancer, and conducted a summary analysis of the clinical treatment options after the progression of CDK4/6 inhibitors.
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | A single-center, real-world study evaluated the clinical outcomes and safety of CDK4/6 inhibitors combined with endocrine therapy in HR+/HER2- advanced breast cancer, and conducted a summary analysis of the clinical treatment options after the progression of CDK4/6 inhibitors. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years old; 2. Patients diagnosed with HR+/HER2- (as defined by the ASCO/CAP guidelines) advanced breast cancer who were treated in our hospital from March 2022 to March 2025; 3. Received CDK4/6 inhibitors (including but not limited to the four currently marketed ones: palbociclib, abemaciclib, ribociclib, and dalpiciclib) as advanced-stage treatment for at least one cycle; 4. Have complete medical history records, including demographic information, pathological reports, treatment records, laboratory test results, and imaging examination reports, etc. Exclusion Criteria: 1. Incomplete medical history data. 2. Only received CDK4/6 inhibitors monotherapy. 3. Received CDK4/6 inhibitors as neoadjuvant/postoperative adjuvant intensification therapy. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Locations | Tianjin, China |
| Start date | 2025-06-01 |
| NCT ID | NCT07407439 |
| Official listing | https://clinicaltrials.gov/study/NCT07407439 |