Grade 1 Endometrial Cancer
Conditions
Brief summary
1. Regression rate at Month 6 assessment, defined as participants who have a decrease in the proportion of cancer or percentage of cancer is not increased but have an increase in non-cancer/non-atypical hyperplasia (%) at the Month 6 assessment compared with baseline, 2. Occurrence and severity of adverse events with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Detailed description
1. Complete regression rate, defined as the participants who have an assessment of 100% of non-cancer/non-atypical hyperplasia at Month 6 assessment, 2. Duration of regression, defined as the time from the first regression to time of the first relapse, 3. Time to regression, defined as the time from the first study treatment to the first regression, 4. Time to relapse or loss of clinical benefit per investigator, defined as the time from the first study treatment to relapse or loss of clinical benefit per investigator, whichever occurs first. Participants will be censored if they have surgery at Month 6 and no relapse or loss of clinical benefit occurs before surgery, 5. Plasma concentration of giredestrant at specified timepoints
Interventions
DRUGRO7197597
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Regression rate at Month 6 assessment, defined as participants who have a decrease in the proportion of cancer or percentage of cancer is not increased but have an increase in non-cancer/non-atypical hyperplasia (%) at the Month 6 assessment compared with baseline, 2. Occurrence and severity of adverse events with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete regression rate, defined as the participants who have an assessment of 100% of non-cancer/non-atypical hyperplasia at Month 6 assessment, 2. Duration of regression, defined as the time from the first regression to time of the first relapse, 3. Time to regression, defined as the time from the first study treatment to the first regression, 4. Time to relapse or loss of clinical benefit per investigator, defined as the time from the first study treatment to relapse or loss of clinical benefit per investigator, whichever occurs first. Participants will be censored if they have surgery at Month 6 and no relapse or loss of clinical benefit occurs before surgery, 5. Plasma concentration of giredestrant at specified timepoints | — |
Countries
Italy, Poland
Outcome results
None listed