Estrogen Receptor Positive HER2 Negative Advanced Breast Cancer
Conditions
Brief summary
Progression-free survival
Detailed description
Objective response rate, Duration of response, Percentage change in tumour size in tumour size at 16 weeks, Overall survival, Clinical benefit rate at 24 weeks, Plasma concentrations of AZD9833 and, if appropriate, metabolite(s), Percent change from baseline in ER and progesterone receptor (PgR) expression assessed by the manual H-score method, Percent change from baseline in Ki67 labelling index., Changes from baseline in total/subscale scores of the HrQoL questionnaires.
Interventions
DRUGFULVESTRANT
DRUGcamizestrant
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, Duration of response, Percentage change in tumour size in tumour size at 16 weeks, Overall survival, Clinical benefit rate at 24 weeks, Plasma concentrations of AZD9833 and, if appropriate, metabolite(s), Percent change from baseline in ER and progesterone receptor (PgR) expression assessed by the manual H-score method, Percent change from baseline in Ki67 labelling index., Changes from baseline in total/subscale scores of the HrQoL questionnaires. | — |
Countries
Belgium, France, Hungary, Italy, Poland, Portugal, Spain
Outcome results
None listed