breast cancer
Conditions
Brief summary
IBTR rate at 5 years., PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS at 24 months
Detailed description
LRR rate at 5 years, CBC rate at 5 years, DM rate at 5 years, BCSS at 5 years, OS at 5 years, Safety, as assessed by the number and grade of participants with reported AEs at 5 years, Individual scales from QLQ-C30 and QLQ-BR45 scores at baseline, 3, 6, 12, 24 months, and 5 years, Rate of cosmesis assessment grade at baseline, 3, 6, 12, 24 months, and 5 years, PROMs HRQoL measured by ELD14 questionnaire (optional) at baseline, 12, 24 months, and 5 years
Interventions
DRUGEXEMESTANE
DRUGANASTROZOLE
DRUGTAMOXIFEN
DRUGLETROZOLE
Sponsors
University Of Florence
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBTR rate at 5 years., PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| LRR rate at 5 years, CBC rate at 5 years, DM rate at 5 years, BCSS at 5 years, OS at 5 years, Safety, as assessed by the number and grade of participants with reported AEs at 5 years, Individual scales from QLQ-C30 and QLQ-BR45 scores at baseline, 3, 6, 12, 24 months, and 5 years, Rate of cosmesis assessment grade at baseline, 3, 6, 12, 24 months, and 5 years, PROMs HRQoL measured by ELD14 questionnaire (optional) at baseline, 12, 24 months, and 5 years | — |
Countries
Italy
Outcome results
None listed