drugset / Trial / NCT06383767
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
Timeline
- Start
- 2024-07-11
- Primary completion
- 2027-06-30
- Completion
- 2028-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | ESG401 | Monoclonal antibody | — | Intravenous |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |