drugset / Trial / NCT07406542
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first- or second-line chemotherapy. It aims to compare the efficacy and safety of SYS6010 monotherapy versus investigator-selected chemotherapy.The study plans to enroll approximately 400 subjects, randomly assigned in a 1:1 ratio to the treatment arm and control arm(Investigator's choice of standard chemotherapy regimen, including eribulin, capecitabine, gemcitabine, or vinorelbine).
Timeline
- Start
- 2026-04-01
- Primary completion
- 2029-04-01
- Completion
- 2030-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | SYS6010 | Monoclonal antibody | — | Intravenous |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |