Breast Cancer
Conditions
Interventions
Dexamethasone 6.6mg Pertuzumab 840mg Trastuzumab 8mg/kg Docetaxel 75mg/m2
Pertuzumab 840mg Trastuzumab 8mg/kg Dexamethasone 6.6mg Docetaxel 75mg/m2
Sponsors
Shizuoka Prefectural Hospital Organization, Shizuoka General Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female patients with histologically confirmed invasive breast cancer 2) No prior treatment with anti-HER2 therapy for breast cancer 3) HER2-positive 4) Any ER, PR. and Ki67-LI are allowed 5) No significant abnormal EKG 6) History of breast cancer and synchronous bilateral breast cancer are allowed unless anti-HER2 therapy was administrated 7) ECOG PS 0-1 8) Sufficient organ function confirmed with following major examination WBC>=3000/mm3 or ANC 1.500 Plt>=100000/mm3 Hb>=9.0g/dL T-Bil<=1.5mg/dL AST,ALT<=2.5 times ULN Cre<=1.5mg/dL No concurrent treatment for cerebral infarction at the registration No history of myocardial infarction and congestive heart failure 9) Operable primary breast cancer 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Serious drug hypersensitivity 2) Pregnant or lactation women, or women with suspected pregnancy 3) Other any cancer 4) Other severe complications AMI, heart failure, purmonary fibrosis, uncontrolled DM, severe infection and so on 5) Severe mental disorders 6) Active bleeding of digestive tract 7) Serious myeloablation, renal insufficciency, liver failure 8) Diarrhea 9) Active infection 10) Prior treatment with anti-HER2 therapy for breast cancer 11) Metastatic breast cancer 12) Under treatment with continuous systemic steroid, anti-allergic agent, anti-histamine agent, immunosuppresant, and NSAID 13) Not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of infusion reactions | — |
Countries
Japan
Contacts
Public ContactShigeru Nakagaki
Shizuoka General Hospital Department of Pharmacy
Outcome results
None listed