Patients with metastatic breast cancer in 1st or 2nd line of chemotherapy
Conditions
Brief summary
Progression-free survival (PFS) is defined as the time from randomization to the first documented progression of disease or death, whatever the cause. The tumor assessments are made by the investigators based on RECIST 1.1 criteria ([Eisenhauer 2009]). Patients still alive at the time of analysis without documented progression (including lost to follow-up) will be censored at the last known alive date.
Detailed description
Overall Survival (OS) is defined as the time from randomization to death due to any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date., Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria. Changes in tumor size over time will also be analysed, Evaluation of safety will be done according to NCI CTCAE v4.03 criteria
Interventions
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
Unicancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) is defined as the time from randomization to the first documented progression of disease or death, whatever the cause. The tumor assessments are made by the investigators based on RECIST 1.1 criteria ([Eisenhauer 2009]). Patients still alive at the time of analysis without documented progression (including lost to follow-up) will be censored at the last known alive date. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) is defined as the time from randomization to death due to any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date., Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria. Changes in tumor size over time will also be analysed, Evaluation of safety will be done according to NCI CTCAE v4.03 criteria | — |
Countries
France
Outcome results
None listed