Breast Cancer Clinical Trials

• 18 years to 75 years old (including boundary values);

• ECOG PS Score: 0\

‣ 1;

• Histologically or cytologically confirmed HER2-negative advanced breast cancer;

• Disease progression after prior ≥1 line of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;

• Based on RECIST v1.1, at least one measurable lesion;

• Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;

• Patients must have a life expectancy ≥ 6 months;

• Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);

• Women of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate; Men who are not surgically sterile (including those sterilized by methods other than bilateral orchiectomy \[e.g., vasectomy\]) and who intend to have sexual intercourse with female partners of childbearing potential must use a contraceptive method from enrollment, throughout the study, and for 6 months after the end of the study to prevent partner pregnancy;

⁃ Available blood samples for ctDNA detection in the exploratory study;

⁃ Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.