This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study includes four groups of patients based on treatment history and tumor characteristics. Each group will receive JSKN016 with chemotherapy or immunotherapy. The goal is to find out how well the treatment works and how safe it is.
Capable of understanding and signing the informed consent form.
Aged ≥18 and ≤75 years, regardless of sex.
Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer.
Hormone receptor-positive participants with progression/intolerance after standard endocrine therapy, or unsuitable for it.
CNS metastasis (except stable cases treated with radiation or surgery).
Unstable spinal cord compression or untreated history.
Recent live vaccine (except seasonal flu vaccines).
Recent anti-tumor treatment within 28 days or 5 half-lives (whichever is shorter).