Overview
The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.
Eligibility
Inclusion Criteria:
- Women aged 18 to 75 (inclusive).
- HER2 low expression unresectable or metastatic breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1.
- An expected survival of ≥ 12 weeks.
- At least one measurable lesion according to RECIST v1.1 criteria.
- Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding.
- Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures.
Exclusion Criteria:
- Have other malignancies within the past 5 years.
- Presence with uncontrollable third space effusion.
- Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.
- Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.
- Clinically significant cardiovascular disorders.
- Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control.
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
- Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products.
- Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption.
- Presence of other serious physical or mental diseases or laboratory abnormalities.