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A ctDNA Screening Program in Patients With HR+, HER2- Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor and a Randomised Phase II Study Comparing Alpelisib Combined With Fulvestrant to Ribociclib Combined With Fulvestrant, in Patients With Persistent Targetable PIK3CA Mutations (SAFIR 03)
After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).
Details
| Lead sponsor | UNICANCER |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 162 |
| Start date | 2023-10-19 |
| Completion | 2030-06 |
Conditions
- Breast Cancer Stage IV
Interventions
- Alpelisib
- Ribociclib
Primary outcomes
- Progression-Free Survival in the study groups — From randomization to disease progression or death, up to 5 years
The PFS is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Countries
France