A Phase III, randomized, two armed, double-blind, parallel, active controlled, non-inferiority clinical trial to compare efficacy and safety of Denosumab (produced by AryoGen Pharmed Co.) versus Denosumab (Xgeva®, produced by Amgen Company) in breast cancer patients with bone metastasis

AryoGen Pharmed Co.0 个研究点目标入组 272 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•Female patients aged 18-75 years old at the time of signing informed consent form ICF
•History or known case of breast adenocarcinoma
•Radiographic evidence of at least one bone metastasis
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
•Adequate organ function: Albumin-adjusted serum calcium = 2.0 mmol/L [= 8.0 mg/dL] and = 2.9 mmol/L [= 11.5 mg/dL], Serum aspartate aminotransferase (AST) =2.5 ULN, Serum alanine aminotransferase (ALT) =2.5 ULN, Serum total bilirubin =2 ULN, Creatinine clearance =30 mL/min (stage 1-3 CKD patients), Serum Creatinine =1.5 ULN, Leukocytes > 3,000/mcL (without growth factor), Platelets > 100,000/mcL,Hemoglobin =8 g/d

•Planned radiation therapy or bone surgery
•Life expectancy less than 6 months
•Known brain and liver metastasis
•Prior administration of Denosumab or IV bisphosphonates
•Non-healed dental/oral surgery
•History or current evidence of osteonecrosis/osteomyelitis of the jaw
•Active dental or jaw condition which requires oral surgery
•Planned invasive dental procedure in the course of the study
•Disorders associated with abnormal bone metabolism including uncontrolled hyperthyroidism or hypothyroidism or Paget’s disease
•Prior malignancy (other than breast cancer, basal cell carcinoma, or in situ cervical cancer) within 3 years prior to randomization
•Known infection with human immunodeficiency virus (HIV)
•Known infection with Hepatitis B or Hepatitis C virus (HBV or HCV)
•Receiving any investigational product or device in other clinical trials 30 days prior to the study
•Allergy to any of the products to be administered during the study (eg, Denosumab, mammalian cell line products, calcium or vitamin D)
•Treatment with calcitonin, parathyroid hormone-related peptides, mithramycin, strontium ranelate, or gallium nitrate within 8 weeks prior to randomization
•Any psychiatric disorder, organ disfunction or systemic disease that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
•Pregnancy or breast feeding

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