Clinical Trial

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

Study acronym: RIBOLARIS
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2022-03-24; most recent amendment 2026-05-11.
Status change: Recruiting → Active, Not Recruiting 2026-05-11
Status change: Not Yet Recruiting → Recruiting 2022-05-31
Trial Details
NCT Number NCT05296746
Lead Sponsor SOLTI Breast Cancer Research Group
Collaborators: Novartis, UNICANCER
Conditions Breast Cancer Stage II
Enrollment 1,100 participants
Start Date 2022-05-03
Primary Completion 2029-10-01 (estimated)
Study Completion 2031-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-14