A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

Inclusion criteria

• 1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 3. Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer. 4.Cohort 1: patients had received ≤1 line of treatment. 5.Cohort 2: patients had not previously received systemic antitumor therapy. 6.Has at least one measurable lesion according to RECIST1.1 criteria. 7.Adequate laboratory indicators.

Exclusion criteria

• 1. Concomitant disease and medical history:

• Has other malignant tumors within 3 years;
• Has multiple factors affecting oral medication;
• Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
• Has active or uncontrolled severe infections before the first dose;
• Cirrhosis, active hepatitis#
• Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment:

<!-- -->

• Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
• Had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose;
• Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

• Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.

• Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.