Study of Outcomes in Adults With HR, HER2- Early-Stage Breast Cancer Treated With CDK46 Inhibitors and Endocrine Therapy

What this Trial Is About

Researchers are studying patients with hormone receptor-positive, HER2-negative early breast cancer HRHER2- EBC who are at high risk of their cancer returning. This observational study includes both past and future phases to assess the clinical and pathological features, treatment choices, and outcomes of patients treated with CDK46 inhibitors ribociclib or abemaciclib combined with endocrine therapy in the adjuvant setting. The study also focuses on patients whose cancer returned during or within 12 months after finishing this adjuvant treatment. Participants are those who have started or are starting adjuvant treatment with ribociclib or abemaciclib along with endocrine therapy since January 1, 2021. This study does not involve assigning treatments but observes patients receiving these therapies in real-world settings. It gathers data on treatment patterns, recurrence, and clinical outcomes without altering patient care. During the study, researchers will collect and analyze data on patient health, tumor characteristics, and treatment responses. They will track invasive disease-free survival over 3 years as the main outcome, along with distant relapse-free survival, progression-free survival, and overall survival up to 5 years. Participants will provide consent for their data to be used, and their health status will be monitored through routine medical records and follow-ups. The study is expected to continue until August 2030.

Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: