drugset / Trial / NCT06764186
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
Phase 3
Active not recruiting
101 enrolled
AstraZeneca
Apices Soluciones S.L. · collabSOLTI Breast Cancer Research Group · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effectiveness and safety of capivasertib + fulvestrant treatment administration in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor.
Timeline
- Start
- 2025-01-07
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capivasertib | Small molecule | 400 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |