metasatic breast cancer, hormon positive, her 2 negative
Conditions
Brief summary
Exposure-adjusted incidence rate of grade 3 or 4 hyperglycemia within the first 3 months or 30 days after the treatment discontinuation whichever comes first
Detailed description
1) Median time to the first grade 3 or 4 hyperglycemia from the first dose of study treatment until 30 days from permanent treatment discontinuation, 2) Exposure-adjusted incidence rate of any grade hyperglycemia within the first 3 months or 30 days after the treatment discontinuation whichever comes first 3) ORR from randomization to 30 days after the treatment discontinuation PFS from randomization to the end of the study 4) Exposure-adjusted incidence rate of all grade hyperglycemia,
Interventions
Sponsors
Croatian Cooperative Group For Clinical Trial Research In Oncology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exposure-adjusted incidence rate of grade 3 or 4 hyperglycemia within the first 3 months or 30 days after the treatment discontinuation whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Median time to the first grade 3 or 4 hyperglycemia from the first dose of study treatment until 30 days from permanent treatment discontinuation, 2) Exposure-adjusted incidence rate of any grade hyperglycemia within the first 3 months or 30 days after the treatment discontinuation whichever comes first 3) ORR from randomization to 30 days after the treatment discontinuation PFS from randomization to the end of the study 4) Exposure-adjusted incidence rate of all grade hyperglycemia, | — |
Countries
Croatia
Outcome results
None listed