JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer

Inclusion Criteria

• •Age ≥18 years
• •Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer
• •HR-positive defined as ER and/or PR ≥1% by IHC
• •HER2-negative per ASCO/CAP guidelines
• •At least one measurable extracranial lesion per RECIST v1.1
• •ECOG performance status 0-1
• •Prior progression on CDK4/6 inhibitor plus endocrine therapy
• •Adequate organ and cardiac function
• •Postmenopausal women, or premenopausal women receiving ovarian function suppression