This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
Male/female who are at least 18 years of age on the day of signing the informed consent.
With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting
Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
Patients with other malignant tumors within 3 years before the randomization
Previous treatment with any HER2-target therapy
Uncontrolled or significant cardiovascular disease or infection
Lung-specific intercurrent clinically significant illnesses