Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
Status:
Not yet recruiting
Trial end date:
2030-07-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multicenter international trial in men and women with primary operable
HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term
efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant
ribociclib and letrozole.
This study aims to evaluate whether chemotherapy could be avoided for initial high-risk
clinicopathological breast cancer patients that are converted to low genomic risk assessed by
Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment
by continuing with this treatment in adjuvant setting.