drugset / Trial / NCT05625087
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
Phase 2
Active not recruiting
162 enrolled
UNICANCER
Breast Cancer Research Foundation · collabNovartis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2023-10-19
- Primary completion
- 2028-07
- Completion
- 2030-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 300 mg | Oral |
| Comparator | Ribociclib | Small molecule | 600 mg | Oral |
| Background | Fulvestrant | Small molecule | 500 mg | — |