Breast Cancer
Conditions
Interventions
Preoperative chemotherapy of docetaxel and trastuzumab
Sponsors
Toukai Breast Cancer Clinical Reserch Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically proven breast cancer with stage IIIB and IIIC 2)HER2 over expression detected by IHC (score3+ and score2+ with HER2 genetic over expression detected by FISH) 3) PS:0-1 4) Aged 20 to 75 years 5)Previously untreated for breast cancer with chemotherapy, radiotherapy, endocrinotherapy, or immunotherapy 6)Bidimentionally measurable disease by CT scan or MRI 7) Sufficient organ function 8)Written informed concent
Exclusion criteria
Exclusion criteria: 1)Drug allergy 2)Distant metastasis 3)Bilateral breast cancer 4)male 5)Double cancer 6)Uncontrollable complication 7)Heart disease 8) LVEF<50% by echocardiogram 9)Cardiac performance class II, III and IV by New York Heart Association Functional Classification 10)Sever infection 11)Motor paralysis or neuropathy 12)Pleural or subpericardial effusion 13)Pregnancy 14)Edema with grade G2 or more 15)Interstitial pneumonia or pulmonary fibrosis 16)Hypersensitivity for polysorubate 17) Positive HBs antigen 18)Psychological disease 19)Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) efficacy 2) safety | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) histologic effect 2) overall survival | — |
Countries
Japan
Contacts
Public ContactHiroji Iwata, M.D.
Aichi Cancer Center Department of Breast Oncology
Outcome results
None listed