Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Hormone receptor (HR) status confirmed by local laboratory.
Patients who have progressed after treatment containing within HER2 ADC
Presence of at least one measurable lesion according to the RECIST v1.1.
Adequate organ function
You may not be if
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.
History of cerebrovascular accident within 6 months prior to randomization.
Current (non-infectious) interstitial lung disease (ILD)/pneumonia that requires steroid treatment.
Active infection.
Active tuberculosis.
Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
Receipt of systemic anti-tumor treatment and immunotherapy, within 4 weeks prior to randomization
Pregnant or lactating women or women who plan to become pregnant during the study period.
History of immunodeficiency or history of organ transplantation.
Clareo Health | A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
