HER2 positive Breast Cancer
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Inoperable, locally advanced/recurrent or metastatic 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 to trastuzumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate based on Efficacy Review Committee assessment RECIST ver. 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Safety, Pharmacokinetics, Anti-RG3502 antibodies RECIST ver. 1.1, CTCAE ver. 4.0 | — |
Outcome results
None listed