Breast Cancer
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Pathologically confirmed breast cancer b) HER2-positive by IHC or ISH c) Locally advanced or metastatic/recurrent breast cancer d) Any prior treatment e) 20 y.o. and over f) ECOG performance status 0-2 g) Adequate interval from prior therapy h) Interval over 2w from prior radiotherapy i) Adequate baseline organ and marrow function as defined below: Platelet count >= 100,000mm3 Hemoglobin >= 7.0g/dL AST and ALT <= 2.5x ULN Serum bilirubin <= 1.5 x ULN j) Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography k) Signed written informed consent
Exclusion criteria
Exclusion criteria: a) Brain metastasis with clinical symptoms b) Uncontrollable body fluid c) Concurrent serious disease or condition Active infection concurrent serious psychiatric disorder Ileus, breeding Uncontrollable angina and mycardial infarction within 3 months, severe heart disease with heart failure d) pregnant or lactating women e) Patient considered irrelevant by attending physician for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and immune response of T-DM1 | — |
Countries
Japan
Contacts
Public ContactAkihiko Shimomura
National Cancer Center Hospital Breast and Medical Oncology
Outcome results
None listed