Study of CDK46 Inhibitors With Standard Adjuvant Endocrine Therapy for Women With High-Risk HRHER2 Early Breast Cancer After Anti-HER2 Treatment

What this Trial Is About

Researchers are evaluating the addition of CDK46 inhibitors combined with standard adjuvant endocrine therapy in women with high-risk hormone receptor-positive HR and HER2-positive early breast cancer who have completed anti-HER2 targeted therapy. This Phase III randomized controlled trial aims to assess the effectiveness and safety of this combination treatment compared to endocrine therapy alone. Participants in this study will be randomly assigned to one of two groups one receiving standard endocrine therapy alone such as Tamoxifen, Anastrozol, Letrozole, or Exemestane, and the other receiving the same endocrine therapy combined with a CDK46 inhibitor for 2 years. The study focuses on patients who have finished adjuvant anti-HER2 therapy within the past year. The trial is open-label, meaning both researchers and participants know which treatment is given. Throughout the 5-year study period, participants will be monitored for invasive disease-free survival as the primary outcome. Secondary outcomes include distant recurrence-free survival, overall survival, safety assessments including adverse events, and patient-reported outcomes over approximately 3 years. Participants will undergo regular follow-up visits and evaluations to assess treatment effects, safety, and quality of life as part of this study sponsored by Fudan University.

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