Triple Negative Breast Cancer
Conditions
Brief summary
iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, or invasive contralateral breast cancer.
Detailed description
OS is defined as the time from the date of randomization until death due to any cause., dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer., RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, Incidence of TEAEs and clinical laboratory abnormalities, TTW of QoL based on FACT-B Trial Outcome Index (TOI) score
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, or invasive contralateral breast cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS is defined as the time from the date of randomization until death due to any cause., dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer., RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, Incidence of TEAEs and clinical laboratory abnormalities, TTW of QoL based on FACT-B Trial Outcome Index (TOI) score | — |
Countries
Belgium, France, Germany, Ireland, Italy, Spain
Outcome results
None listed