Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
Neoadjuvant and Adjuvant Ribociclib and Endocrine Therapy for Clinically High-risk Estrogen Receptor-positive (ER+) and HER2-negative (HER2-) Breast Cancer
SOLTI Breast Cancer Research Group
1,100 participants
May 3, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
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Interventions
Ribociclib 600 mg/day + letrozole during neoadjuvant phase.
Adjuvant chemotherapy. 3 regimens are permitted.
Ribociclib 400 mg/day + letrozole (or other aromatase inhibitor) during adjuvant phase.
Locations(51)
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NCT05296746