A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults

A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer

The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.

Inclusion Criteria:

1. ECOG performance status score: 0-1;
2. Histopathologically documented local advanced or metastatic breast cancer ;
3. Female of not childbearing potential must the related requirement;
4. During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
5. Adequate organ functions as defined;
6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

1. For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
3. History of clinically significant cardiovascular or cerebrovascular diseases;
4. The subject has one of many factors affecting oral drugs;
5. Active infection or fever with unknown cause > 38.5 °C;
6. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
7. Known history of allergy to study drug ingredients.