Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.
Breast cancer patients by histopathology and/or cytology documented.
In the advanced or metastatic stage, having received no more than 5 lines of systemic therapy, one of which must include a HER2 ADC with a topoisomerase inhibitor payload.
Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.
Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.
Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.
Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.
Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.
Single group
A166
Drugintravenous(IV) infusion (Q3W)
Objective response rate(ORR)
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by investigator per RECIST 1.1
Progression-free survival (PFS)
PFS, 6-month PFS, 12-month PFS.PFS as assessed by investigator according to RECIST v 1.1
Overall survival (OS)
OS, 1-year survival rate, 1.5-year survival rate, and 2-year survival rate.OS defined as time from inclusion until death
Disease control rate(DCR)
DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by investigator per RECIST 1.1
Duration of response(DOR)
DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by investigator or death due to any cause, whichever occurs first.
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