This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.
Voluntarily agree to participate in the study and sign the informed consent;
Subjects aged 18-70 years (including 18 years and 70 years) and not reaching the 71st birthday were all considered to be ≤70 years old;
Expected survival ≥12 weeks;
Eastern Cooperative Oncology Group(ECOG) physical condition 0 or 1;
Received chemotherapy within 4 weeks before the start of study administration (treatment with nitrosourea and mitomycin C within 6 weeks, oral fluorouracil within 2 weeks), radiotherapy (palliative for bone metastases Local radiotherapy is within 2 weeks before study administration), immunotherapy; received endocrine therapy for breast cancer within 2 weeks before study administration;
The research drug was used within 4 weeks before the start of study administration;
Have undergone major surgery within 4 weeks before the start of study administration;
Have received a live vaccine within 4 weeks before the start of study administration or plan to receive any vaccine during the study period;
Parallel
RC48-ADC
DrugRC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks
Paclitaxel Injection
DrugAdministered according to label, as one option for Physician's Choice (determined before randomization)
Docetaxel Injection
DrugAdministered according to label, as one option for Physician's Choice (determined before randomization)
Vinorelbine Tartrate Injection
DrugAdministered according to label, as one option for Physician's Choice (determined before randomization)
Capecitabine Tablets
DrugAdministered according to label, as one option for Physician's Choice (determined before randomization)
Progression-free survival (PFS), evaluated by an independent efficacy evaluation committee
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Progression-free survival (PFS), evaluated by the investigator
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Objective remission rate (ORR)
The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).
Duration of relief (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Disease control rate (DCR)
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
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