This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).
Aged ≥ 18 years (or the legal age of adulthood per country-specific regulation) at the time of signing the ICF, male or female.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or - Life expectancy of ≥ 6 months.
Histologically confirmed breast cancer with radiologically or otherwise documented locally advanced unresectable and/or metastatic disease.
HER2 positive confirmed by central laboratory.
History of any other malignancy within 2 years prior to signing the ICF.
Prior use of doxorubicin with a cumulative in vivo dose of > 360 mg/m2.
Adverse events from prior anti-tumor treatment that have not resolved to Grade ≤ 1 or baseline level according to CTCAE v6.0.
Uncontrolled or severe cardiovascular disease.
Parallel
HLX22
Drug15 mg/kg, intravenous infusion (IV) on Day 1 (D1) of Q3W
Trastuzumab
DrugLoading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.
Capecitabine
Drug1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W
Paclitaxel
Drug175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV
Docetaxel
Drug75-100 mg/m2, D1, Q3W, IV
Eribulin
Drug1.4 mg/m2, D1 and D8, Q3W, IV
Vinorelbine
Drug25-30 mg/m2, D1 and D8, Q3W, IV
Objective response rate (ORR) assessed by the blinded independent central review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1
Progression-free survival (PFS) assessed by the BICR as per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
ORR assessed by the investigator as per RECIST 1.1
PFS assessed by the investigator as per RECIST 1.1
Duration of response (DoR) assessed by the BICR and the investigator as per RECIST 1.1
DoR is defined as the time from the date of first achievement of CR or PR (whichever is documented first) to the date of the first documentation of PD or death (whichever occurs first)
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