Clinical Trial

A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer

Not Yet Recruiting Phase 3
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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).
Trial Details
NCT Number NCT07406542
Lead Sponsor CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions Recurrent or Metastatic Breast Cancer
Enrollment 400 participants
Start Date 2026-04-01
Primary Completion 2029-04-01 (estimated)
Study Completion 2030-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-12