1. Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
2. When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer
3. ECOG Performance Status of 0 or 1
4. Patient must have adequate tumor sample for biomarker assessment
5. At least one measurable lesion
6. Adequate organ function
You may not be if
1. There are untreated or active central nervous system (CNS) tumor metastases
2. There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion)
3. Major surgery within 4 weeks prior to enrollment
4. Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
5. Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
6. Uncontrolled intercurrent illness
7. Uncontrolled or significant cardiovascular disease
8. Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
9. According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment
Clareo Health | A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
