A Real-world Study on the Treatment of HR+/HER2- Advanced Breast Cancer Patients With CDK4/6 Inhibitors and Treatment Options After Drug Resistance.
Status: Recruiting
Location: See location...
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years old;
• 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;
• 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;
• Have complete medical history records, including demographic information, pathological reports, treatment records, laboratory test results, and imaging examination reports, etc.
Locations
Other Locations
China
Tianjin Medical University Cancer Insititute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Yehui Shi, MD
shiyehui@tjmuch.com
022-23340123-3252
Backup
Yiran Si, MD
022-23340123-3252
Time Frame
Start Date:2025-06-01
Estimated Completion Date:2027-06-01
Participants
Target number of participants:245
Treatments
Palbociclib cohort
Use palbociclib in combination with endocrine therapy as the treatment regimen.
Abemaciclib cohort
Use abemaciclib in combination with endocrine therapy as the treatment regimen.
Ribociclib cohort
Use ribociclib in combination with endocrine therapy as the treatment regimen.
Dalcetrapib cohort
Use dalcetrapib in combination with endocrine therapy as the treatment regimen.
Other CDK4/6 inhibitors cohort
Use other CDK4/6 inhibitors in combination with endocrine therapy (including participation in clinical trials of CDK4/6 inhibitors) as the treatment regimen.