Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
Conditions
Brief summary
Invasive disease-free survival (IDFS), defined as the time from randomization to first occurrence of one of the following IDFS events; ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, and death from any cause
Detailed description
Overall survival, defined as the time from randomization to death from any cause, IDFS (per STEEP), including second primary non-breast cancer, defined in the same way as the primary IDFS, but including second primary non-breast invasive cancer as an event (with the exception of non-melanoma skin cancers and in situ carcinomas of any site), Disease-free survival (DFS), defined as the time from randomization to first occurrence of an IDFS (per STEEP) event, including second primary non-breast cancer event or contralateral or ipsilateral DCIS, Distant recurrence-free interval (DRFI), defined as the time from randomization to first occurrence of a DRFI event, Locoregional recurrence-free interval (LRRFI), defined as the time from randomization to first occurrence of an LRRFI event, Mean and mean change from baseline in physical functioning, role functioning, and global health status/QoL at relevant timepoints as assessed through use of the European Organisation for the Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30) respective scale scores, Incidence and severity of adverse events, with severity determined according to NCI CTCAE 5.0, Change from baseline in targeted vital signs and clinical laboratory test results, Plasma concentrations of giredestrant at specified timepoints, Change from baseline in EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L) index-based and visual analogue scale scores at relevant timepoint
Interventions
DRUGVerzenios 50 mg film-coated tablets
DRUGcomprimé pelliculé
DRUGRO7197597
DRUG5 mg
DRUGTamoxifen 20 PCH
DRUGtabletten 20 mg
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival (IDFS), defined as the time from randomization to first occurrence of one of the following IDFS events; ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, and death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, defined as the time from randomization to death from any cause, IDFS (per STEEP), including second primary non-breast cancer, defined in the same way as the primary IDFS, but including second primary non-breast invasive cancer as an event (with the exception of non-melanoma skin cancers and in situ carcinomas of any site), Disease-free survival (DFS), defined as the time from randomization to first occurrence of an IDFS (per STEEP) event, including second primary non-breast cancer event or contralateral or ipsilateral DCIS, Distant recurrence-free interval (DRFI), defined as the time from randomization to first occurrence of a DRFI event, Locoregional recurrence-free interval (LRRFI), defined as the time from randomization to first occurrence of an LRRFI event, Mean and mean change from baseline in physical functioning, role functioning, and global health status/QoL at relevant timepoints as assessed through use of the European Organisation for the Research and Treatm | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
Outcome results
None listed