A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations

Exclusion Criteria

• •1\) Pregnant or lactating women. 2) Active inflammatory breast cancer. 3) Previous treatment with other PARP inhibitor drugs, including but not limited to TSL-1502, Olaparib, Talazoparil, Fluzoparil, Nilaparib, Rucaparib, Veliparib, etc. 4) Known to be allergic to TSL-1502 or any excipient of TSL-1502 capsules. 5) Known to have active brain metastases (defined as meeting any of the following: stable neurological imaging \< 4 weeks; symptoms related to brain metastasis; steroid therapy required; leptomeningeal disease); patients must have completed any prior treatment for brain metastases ≥ 4 weeks prior to the first dose.
• •6\) Patients with previous or current another malignancy. 7) Have other serious or uncontrollable clinical diseases or past medical history, surgical history, including but not limited to hepatic/renal dysfunction, respiratory disorders, endocrine disorders, metabolic disorders, neuropathy, or mental disorders, organ transplantation, etc.
• •8\) Gastrointestinal or digestive system diseases that may affect the absorption of investigational products as judged by the investigator or past medical history, such as intractable hiccups, nausea, vomiting, chronic gastrointestinal disease (e.g. Ron's disease, ulcerative colitis, active gastric ulcer, etc.), dysphagia, etc.
• •9\) Have serious cardiovascular system disease or past medical history (meet any of the following conditions); Definite cardiovascular abnormality within 6 months prior to first dose (e.g., myocardial infarction, cardiac arrhythmia, angina pectoris, angioplasty, vascular stent implantation, coronary artery bypass surgery, congestive heart failure, etc.); Baseline electrocardiogram QT or Fridericia-corrected QT interval (QTcF) prolongation \[QTcF = QT/(RR 0.33), QTcF \> 480 ms\]; Left ventricular ejection fraction \< 50% by cardiac ultrasound; Uncontrolled hypertension (Patients with blood pressure ≥150/100 mmHg after lifestyle improvement and medication) 10) Participated in clinical trials of other drugs or medical devices within 4 weeks prior to initial administration (note: except for those who did not use investigational drugs or medical devices).
• •11\) Patients who underwent major surgery or significant traumatic injury within 4 weeks prior to initial administration, or who planned to undergo major surgery in the trial period.
• •12\) Chemotherapy, radiotherapy, non-hormone targeted therapy, endocrine therapy, Anti-neoplastic immunotherapy \[physiologic replacement doses of corticosteroids permitted (prednisone or equivalent \< 15 mg/day)\], Chinese medicine therapy with a clear indication for the treatment of breast cancer, or other anti-tumor therapy were received within 4 weeks prior to initial administration.
• •13\) AEs related to previous surgery and previous anti-tumor therapy (CTCAE version 5.0) did not recover to ≤ 1 grade (alopecia, pigmentation, platinum-induced neurotoxicity grade 2 and lower, except for clinically significant or asymptomatic laboratory abnormalities).
• •14\) Patients who had received a CYP2D6 liver enzyme inhibitors or inducers within 2 weeks prior to initial dosing, or who cannot discontinue the use of CYP2D6 liver enzyme inhibitors or inducers during the trial.
• •15\) Patients who test positive for treponema pallidum antibody, human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) RNA, or active hepatitis B patients \[defined as hepatitis B virus (HBV) DNA ≥ ULN\].
• •16\) The investigator considered that patients have other conditions that might affect compliance or are not suitable for participating in this trial.