Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer
Conditions
Brief summary
Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])., Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).
Detailed description
Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)., Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline over time., Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12., Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])., Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD)., Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)., Mean change in frequency of moderate to severe HF from baseline over time., Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12., Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12. | — |
Countries
Austria, Belgium, Finland, France, Germany, Hungary, Ireland, Italy, Poland, Portugal, Romania, Spain