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

NCT07406542 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-02-12

No results posted yet for this study

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).

Conditions

  • Recurrent or Metastatic Breast Cancer

Interventions

DRUG

SYS6010

SYS6010, intravenous infusion

DRUG

Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)

eribulin 1.4 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W Capecitabine 1000-1250 mg/m² orally Twice daily, Days 1-14, Q3W Gemcitabine 1000 mg/m² Intravenous infusion Administered on Days 1 and 8, Q3W Vinorelbine 25 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-04-01
Completion
2030-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07406542 on ClinicalTrials.gov