A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.
• Females aged 18-75 years old (both ends inclusive);
• ECOG performance status (PS) 0-1 points;
• Patients with metastatic or locally advanced breast cancer confirmed by histology(ER positive, HER2 positive/negative,or triple negative breast cancer).
• Tumor tissue samples must be provided for detection of tumor markers;
• Menopausal state;
• Disease progression confirmed by imaging during or after the last systemic treatment before enrollment;
• There must be at least one measurable extracranial lesion that complies with RECIST v1.1;
• Expected survival \>3 months;
• Good functional level of the organs ;
⁃ Female subjects with childbearing potential must agree to use highly effective contraceptive measures during the study treatment period and within 7 months after the end of the study treatment period; female subjects with childbearing potential must agree to use serum serum within 7 days before study enrollment. The HCG test must be negative and the patient must be non-lactating;
⁃ Voluntarily participate in this clinical trial, be willing and able to comply with clinical visits and research-related procedures, understand the research procedures and have signed informed consent.