Breast cancer. Malignant neoplasm of unspecified site of unspecified female breast
Conditions
Interventions
Intervention 1: Denosumab (produced by AryoGen Pharmed Co.), Subcutaneous, 120 mg once every 4 weeks for 80 weeks (21 doses). Intervention 2: Xgeva®(produced by Amgen Co.), Subcutaneous, 120 mg once e
Sponsors
AryoGen Pharmed Co.
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first on-study Skeletal-Related Event (SRE). Timepoint: During a 21 months period (with monthly physician visits and imaging every 3 months). Method of measurement: The time from the date of randomization to first SRE including date of pathologic fracture, radiation or surgery to bone, or spinal cord compression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first and subsequent (multiple) Skeletal Related Event (SRE). Timepoint: During a 21-month period (with monthly physician visits and imaging every 3 months). Method of measurement: The time from the date of randomization to first and subsequent SRE.;Safety Outcomes. Timepoint: During a 21-month period. Method of measurement: Safety will be assessed based on clinical examinations and laboratory test results.;Immunogenicity. Timepoint: Weeks 0, 24, 52, 84. Method of measurement: Blood test and antidrug antibody (ADA) presence evaluation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
Orchid Pharmed Co.
Outcome results
None listed