Recruiting
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.
ClinicalTrials.gov IDNCT07407439
PhaseNot Applicable
Enrollment245
SponsorTianjin Medical University Cancer Institute and Hospital
Age18 Years and older
SexALL
Conditions studied
Breast Cancer
About this study
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.
Primary outcomes
- rwPFS1 and rwPFS2 (6 weeks)
Eligibility information
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.
Study locations
- Tianjin Medical University Cancer Insititute and Hospital, Tianjin, 300060 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.