HER2 positive Breast Cancer
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inoperable advanced or recurrent breast cancer; HER2-positive (FISH + or IHC 3+); ECOG PS :0-2
Exclusion criteria
Exclusion criteria: Clinically significant cardiac disease; Grade 3 or higher Hypersensitivity for trastuzumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, pharmacokinetics CTCAE 4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Decreased LVEF, Anti-RG3502 antibodies and anti-RG1273 antibodies RECIST 1.0 | — |
Outcome results
None listed