A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male/female who are at least 18 years of age on the day of signing the informed consent.
2. With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
3. 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
4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
5. ECOG PS: 0-1.
6. Expected survival ≥ 6 months.
7. Had adequate organ function
You may not be if
1. Patients with other malignant tumors within 3 years before the randomization
2. Previous treatment with any HER2-target therapy
3. Uncontrolled or significant cardiovascular disease or infection
5. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
6. Patients with spinal cord compression or clinically active central nervous system metastases
Clareo Health | A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
