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).
Age 18 to 75 years inclusive, no gender restrictions.
Histopathologically confirmed breast cancer at an unresectable recurrent or metastatic stage, requiring: a) HER2-negative; b) EGFR-positive expression.
Subjects must have received 1 to 2 lines of systemic chemotherapy regimens during the unresectable advanced or metastatic stage.
At least one measurable lesion confirmed by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Brain metastases are evaluated only as non-target lesions. Patients with skin lesions only are ineligible.
Presence of cancerous meningitis, spinal cord compression, or active central nervous system metastases. Active central nervous system metastases are specifically defined as untreated, symptomatic, or requiring corticosteroids/anticonvulsants to control related symptoms; except for cases stable for at least one month following treatment for brain metastases and having discontinued corticosteroids/anticonvulsants for >2 weeks.
Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (including clinically significant recurrence requiring additional intervention within 2 weeks prior to enrollment).
History of other malignancies within 3 years prior to first use of study drug, except for: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, and cervical carcinoma in situ
Prior treatment with topoisomerase I inhibitors (including ADCs)
Parallel
SYS6010
DrugSYS6010, intravenous infusion
Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
Drugeribulin 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
PFS
PFS(progression free survival) assessed by BICR based on RECIST v1.1 criteria
OS (overall survival)
Overall survival is defined as the time from randomization to death from any cause.
Progression-Free Survival (PFS) Assessed by Investigator
Progression-free survival assessed by the investigator is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by both BICR and the investigator.
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1, as assessed by both BICR and the investigato.
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