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

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07406542
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Recurrent or Metastatic Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Apr 1, 2029
Completion
Apr 1, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6010
  • Active Comparator: Investigator's Choice of Chemotherapy
    eribulin, capecitabine, gemcitabine, or vinorelbine

Primary Outcome Measure

PFS [ Time Frame: Randomization up to approximately 36 months ]

Central Contacts