OncRef

Clinical Trial: NCT05296746

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:SOLTI Breast Cancer Research Group
Information Provided By:SOLTI Breast Cancer Research Group
Last Update Posted:2026-05-14

Study Overview

Brief 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.

Official Title

Neoadjuvant and Adjuvant Ribociclib and Endocrine Therapy for Clinically High-risk Estrogen Receptor-positive (ER+) and HER2-negative (HER2-) Breast Cancer

Conditions

Breast Cancer Stage II

Intervention / Treatment

  • Drug: Ribociclib (neoadjuvant)
  • Drug: Chemotherapy (adjuvant)
  • Drug: Ribociclib (adjuvant)

Other Study ID Numbers

  • SOLTI-1911
  • BIG-21-02

Start Date (Actual)

2022-05-03

Primary Completion Date (Estimated)

2029-10-01

Study Completion Date (Estimated)

2031-12-01

Enrollment (Estimated)

1100

Study Type

Interventional

Phase

Phase 2