Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX®

Exclusion Criteria

• •Any evidence of distant metastatic lesions.
• •Have received any neoadjuvant /adjuvant endocrine therapy for breast cancer previously.
• •Have received a bilateral oophorectomy, ovarian radiotherapy, hypophysectomy or adrenalectomy, or who have pituitary lesions.
• •Have received major surgery within 4 weeks prior to randomization.
• •History or presence of another malignancy, other than surgically removed squamous/basal cell carcinoma of the skin or radically resected in situ cervical carcinoma, within the last 5 years.
• •Presence of infectious diseases requiring intramuscular or intravenous drug therapy at the screening visit.
• •Suffering from serious diseases within 6 months before the screening visit, including but not limited to: acute coronary syndrome, coronary revascularization, New York Heart Association (NYHA) class ≥ II cardiac insufficiency, severe unstable arrhythmia; Or the presence of fundus disease, severe osteoporosis, uncontrolled seizures, extensive bilateral lung disease diagnosed by high-resolution computed tomography, mental diseases that prevent the signing of informed consent at the screening visit.
• •History of bleeding diathesis (i.e., disseminated intravascular coagulation \[DIC\] or clotting factor deficiency) or long-term anti-coagulant therapy (other than anti-platelet therapy).
• •History of deep venous thrombosis, pulmonary embolism or stroke.
• •Total bilirubin \>1.5xULN, ALT or AST \>2.5xULN, platelets \<90 × 10\^9/L, QTc interval \>460ms, creatinine clearance \< 30 mL/min (calculated according to Cockcroft-Gault formula) at the screening visit.
• •Patients who are seropositive for hepatitis B surface antigen (HBsAg) must meet the following 2 conditions at the same time: 1. HBV DNA level: HBeAg-positive patients, HBV DNA ≥ 20,000 IU/ml \[equivalent to 10\^5 copies/mL\]; HBeAg-negative patients, HBV DNA ≥ 2,000 IU/ml \[equivalent to 10\^4 copies/mL\]; 2. ALT ≥ 2 x ULN).
• •Patients who are seropositive for any one of hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) or anti-treponema pallidum antibody (TP-Ab).
• •Known to be allergic to the active ingredients or any excipients of GnRH analogues or tamoxifen.
• •Unwilling to stop taking any drug that affects sex hormonal status.
• •Have received any investigational drug, any investigational biological product or any investigational medical device, and discontinued within 1 month or 5 half-lives of the corresponding drug before the screening visit, whichever is longer.
• •Female patients who are pregnant or breast-feeding.
• •Other conditions considered unsuitable for enrollment by the investigator.