None listed
Conditions
Interventions
GROUP 1 Type of group
Sponsors
AMGEN INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adults (including males) with histologically or cytologically confirmed breast adenocarcinoma 2) Current or previous radiographic evidence of at least 1 bone metastasis. 3) Performance level 0, 1 or 2 of the Cooperation Group in Eastern Oncology (ECOG). 4) A suitable organic function: a) AST ≤ 5 x upper limit of the normal value (ULN). b) ALT ≤ 5 x ULN. c) Total bilirubin ≤ 2 x ULN. d) Clearance of creatinine (Cockcroft-Gault) ≥ 30 mL / min. e) Serum calcium adjusted for albumin ≥ 2.0 mmol / L (8.0 mg / dL) and ≤ 2.9 mmol / L (11.5 mg / dL). 5) The corresponding written informed consent must be obtained before carrying out any specific procedure of the study.
Exclusion criteria
Exclusion criteria: 1) Current or previous administration of IV bisphosphonates for any reason. 2) Current or previous administration of oral bisphosphonates for the treatment of bone metastases. 3) Radiotherapy or bone surgery planned or previous administration of denosumab. 4) Known brain metastases or life expectancy less than 6 months. 5) Previous history or current evidence of osteonecrosis / osteomyelitis of the jaw. 6) An active dental or jaw condition that requires oral surgery. 7) Unhealed dental / oral surgery. 8) An invasive dental procedure planned during the course of the study. 9) Evidence of any of the following conditions: a) Known antecedents of a second malignant disease within the last 3 years. b) Known infection with the human immunodeficiency virus. c) Active infection with hepatitis B virus or hepatitis C. d) Any disorder that could prevent the subject from completing the study or that could interfere with the interpretation of the study results. e) Thirty days or less of having received a product or device under investigation in another clinical trial. f) Subject with capacity to procreate that does not accept to use an effective contraceptive method. g) Known sensitivity to any of the products to be administered during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to determine the time to the first SRE or related bone event, defined as pathological fracture (s) (vertebral or non-vertebral), bone radiotherapy (including the use of radioisotopes), surgery on bone, or compression of spinal cord. Fractures will be confirmed by bone x-rays and in the case of spinal cord compression, by MRI or CT. Measure:Time to the first SRE. Timepoints:When an event occurs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Time from randomization to the first SRE. 2) Time from the first SRE to a subsequent SRE: To be considered a subsequent SRE, 21 days must have elapsed from the first SRE. A clinical evaluation will be carried out to determine the SREs defined as pathological fracture (s) (vertebral or non-vertebral), bone radiotherapy (including the use of radioisotopes), bone surgery, or spinal cord compression. Fractures will be confirmed by bone x-rays and in the case of spinal cord compression, by MRI or CT. Measure:1) Time to the first SRE in the study. 2) Time to the first and subsequent SRE in the study. Timepoints:When an event occurs. ; Outcome name:1) Emerging adverse events: Clinical evaluation where any harmful medical event will be detected in a patient who was administered a pharmaceutical product and who does not necessarily have a causal relationship with the treatment. The severity, the relationship with the study medication, the actions taken against it and the previous experiences with the event will be evaluated. 2) Laboratory: Panels of hematology and serum chemistry, urinalysis. 3) Anti-denosumab antibodies: They represent an indicator of resistance to treatment, the presence and level of these will be evaluated, whether they are binding or neutralizing. Measure:Security: 1) Incidence of emerging adverse events. 2) Changes in laboratory values. 3) Incidence of anti-denosumab antibody formation. Timepoints:1) Adverse events, laboratory analysis: Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45 and 49 at the end of the study. 2) Anti-denosumab antibodies: Before starting treatment, at weeks 25 and 49 and at the end of the study. ; Outcome name:1) Time to the first SRE (defined above) or HCM; or hypercalcemia of the malignant tumor, defined as a grade 2 serum calcium or ≥ 11.6 mg / dL. 2) Time to first radiotherapy in bone: Clinical evaluation that will determine when radiotherapy is necessary, for pain control | — |
Countries
Austria, Czech Republic, Denmark, Estonia, Germany, Hungary, Italy, Latovia, Lithuania, Netherlands, Spain, Sweden, United Kindgdom
Outcome results
None listed