Clinical Trial

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)

Recruiting Phase 3
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Summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-11.
Status change: Not Yet Recruiting → Recruiting 2026-01-16
Trial Details
NCT Number NCT07019363
Lead Sponsor Fudan University
Conditions Breast Cancer, Adjuvant Therapy
Enrollment 1,903 participants
Start Date 2025-06-15
Primary Completion 2029-05-15 (estimated)
Study Completion 2033-04-15 (estimated)
Updated on ClinicalTrials.gov 2026-01-21