Solid Malignant Tumors
Conditions
Brief summary
AEs, serious adverse events (SAEs), AEs leading to pertuzumab discontinuation or dose interruption, and non-serious AEs of special interest (AESIs) Adverse events will be classified according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]
Detailed description
1. Assessments of Progression free survival (PFS) will be done per Investigator’s assessment, based on local institution’s standard of care, 2. Overall Survival (OS)
Interventions
DRUGPerjeta 420 mg concentrate for solution for infusion
DRUGHerceptin 150 mg powder for concentrate for solution for infusion
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, serious adverse events (SAEs), AEs leading to pertuzumab discontinuation or dose interruption, and non-serious AEs of special interest (AESIs) Adverse events will be classified according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessments of Progression free survival (PFS) will be done per Investigator’s assessment, based on local institution’s standard of care, 2. Overall Survival (OS) | — |
Countries
Italy, Portugal, Spain
Outcome results
None listed