A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer

Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
* Age: 18 to 75 years old; female patient, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer.
* Patients who have been treated with endocrine therapy and have experienced disease progression.
* Patients previously treated with any CDK4/6 inhibitor and not treated with BCL-2 inhibitor.
* Has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
* The main organs function well;
* Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion Criteria:

* 1\. Concomitant disease and medical history:

  1. There were other malignant tumors in 3 years before the first medication.
  2. Has multiple factors affecting oral medication;
  3. Unalleviated toxicity ≥ grade 1 due to any previous therapy;
  4. Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study; e．Arteriovenous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; f．Have a history of psychotropic drug abuse and can not quit or have mental disorders; g．Subjects with any severe and / or uncontrolled disease included: Cirrhosis, active hepatitis, history of immunodeficiency;
* Tumor-related symptoms and treatment:

  1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
  2. have received radiotherapy, other antineoplastic therapy within 2 weeks prior to the first dose;
  3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
* Known hypersensitivity to TQB3909, LHRH agonists (e.g., goserelin), or any excipients.
* Subjects who have received the vaccine within 28 days prior to the first dose, or are planning to receive the vaccine during the study period.
* Has Participated in other clinical trials within 4 weeks before first dose.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.