advanced breast cancer
Conditions
Brief summary
incidence of dose-limiting toxicity
Detailed description
Tolerance: incidence of AEs and Serious Adverse Events (SAE) presented by grade according to the NCI-CTCAE v5.0., overall response rate (ORR) as defined as the percent of patients with a complete response (CR) or a partial response (PR) (RECIST v1.1)., The progression-free survival (PFS) as defined as the interval between the date of inclusion and the date of progression or death. A patient alive and without progression will be censored at the last date of follow-up., PK evaluation will be performed on typical individual pharmacokinetics parameters (
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of dose-limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance: incidence of AEs and Serious Adverse Events (SAE) presented by grade according to the NCI-CTCAE v5.0., overall response rate (ORR) as defined as the percent of patients with a complete response (CR) or a partial response (PR) (RECIST v1.1)., The progression-free survival (PFS) as defined as the interval between the date of inclusion and the date of progression or death. A patient alive and without progression will be censored at the last date of follow-up., PK evaluation will be performed on typical individual pharmacokinetics parameters ( | — |
Countries
France