2상모집 중단 (진행 중)
Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
연구 개요
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.
- 스폰서
- 협력: 노바티스
- 적응증
- Breast Cancer Stage II
- 중재
- Ribociclib (neoadjuvant), Chemotherapy (adjuvant), Ribociclib (adjuvant)
- 목표 등록
- 1,100명
- 시작일
- 2022-05-03
- 완료(예정)
- 2031-12-01
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