The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload
Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
Male or female subjects aged 18 to 75 years (including 18 and 75 years).
ECOG 0-1.
Histopathological diagnosed triple-negative breast cancer.
Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions.
Preexisting peripheral neuropathy Grade ≥ 2.
Hemoglobin A1C (HbA1c) ≥ 8%.
Has ocular conditions or symptoms that may increase the risk of the study.
Parallel
9MW2821
DrugSubjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
Chemotherapy
DrugParticipants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine.
Overall Survival
Time from the date of randomization until the date of death from any cause
Objective Response Rate per investigator
The percentage of subjects who experience a best response of either CR or PR.
Duration of Response per investigator
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause.
Time to response per investigator
Time from the date of randomization to the date of CR or PR.
Disease Control Rate per investigator
The percentage of subjects who experience a best response of CR, PR or stable disease (SD).
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