Evaluation of efficacy and safety of Denosumab (produced by AryoGen Pharmed Co.) versus Denosumab (Xgeva®, produced by Amgen Co.)

Phase 3

• Conditions: Malignant neoplasm of unspecified site of unspecified female breast; C50.919; Breast cancer.

• Registration Number: IRCT20150303021315N21
• Lead Sponsor: AryoGen Pharmed Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 272

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.