drugset / Trial / NCT06635447
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, two-cohorts, phase IIIb study of Capivasertib+Fulvestrant in HR+/HER2-ABC who had disease recurrence/progression following 1-2L endocrine therapy. The Primary objective is to assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1.
Timeline
- Start
- 2024-09-26
- Primary completion
- 2026-10-31
- Completion
- 2027-01-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capivasertib | Small molecule | 400 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intravenous |