drugset / Trial / NCT05296746
Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
Phase 2
Active not recruiting
1100 enrolled
SOLTI Breast Cancer Research Group
Novartis · collabUNICANCER · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-05-03
- Primary completion
- 2029-10-01
- Completion
- 2031-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 400 mg | — |
| Subject | Ribociclib | Small molecule | 600 mg | — |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 830 mg/m2 | — |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 75 mg/m2 | — |
| Background | Epirubicin | Small molecule | 100 mg/m2 | — |
| Background | Letrozole | Other / unclassified | 2.5 mg | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |