Symptomatic bone metastases from breast cancer
Conditions
Brief summary
PFS (progression-free survival, understood as the time between signing the informed consent to the study and documented disease progression or death from any cause), Reduction of pain from bone metastases, QOL (quality of life)
Detailed description
OS (Overall Survival, understood as the time between signing the informed consent to the study and death from any cause), Survival free from symptomatic skeletal events, Time to total alkaline phosphatase (ALP) progression (calculated from baseline to the first quantitative increment), Reduction in ALP value (calculated from baseline to the maximum reduction recorded during treatment/follow-up)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (progression-free survival, understood as the time between signing the informed consent to the study and documented disease progression or death from any cause), Reduction of pain from bone metastases, QOL (quality of life) | — |
Secondary
| Measure | Time frame |
|---|---|
| OS (Overall Survival, understood as the time between signing the informed consent to the study and death from any cause), Survival free from symptomatic skeletal events, Time to total alkaline phosphatase (ALP) progression (calculated from baseline to the first quantitative increment), Reduction in ALP value (calculated from baseline to the maximum reduction recorded during treatment/follow-up) | — |