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

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 t

Trial Details

NCT ID
NCT05296746
Phase
PHASE2
Sponsor
SOLTI Breast Cancer Research Group
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Ribociclib (neoadjuvant)
  • Chemotherapy (adjuvant)
  • Ribociclib (adjuvant)
Locations (sample)
  • Avignon, France|43.94834,4.80892
  • Bayonne, France|43.49316,-1.473
  • Besançon, France|47.24878,6.01815
  • Blois, France|47.59432,1.32912
  • Caen, France|49.18585,-0.35912

Key Eligibility Criteria

  • Signed Informed Consent Form prior to any study-specific procedure. Patients must be willing and able to comply with the protocol for the duration …
  • Note: Candidate patients in France must be affiliated to a Social Security System (or equivalent)
  • Male (≥18 years old) or pre-menopausal women (≥40 years old) or post-menopausal women. Premenopausal/male patients will receive LHRH agonists 2 wee…
  • Age ≥60 years or

For full eligibility, visit ClinicalTrials.gov.

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