Breast Neoplasms
Conditions
Brief summary
Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of carboplatin. The investigators expect to carry out a large sample size clinical research to optimize the existing therapeutic regimen
Interventions
DRUGEpirubicin
75mg/m2 d1 evry 21days
DRUGDocetaxel
75mg/m2 d1 evry 21days
DRUGTrastuzumab
6mg/kg(loading dosage is 8mg/kg)
DRUGCarboplatin
Area Under Curve(AUC)=6 d1 evry 21days
Sponsors
Hospital Affiliated to Military Medical Science, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* 18≤aged\<70 * pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by MRI or axillary lymph node（+） * Immunohistochemical（IHC） positive for 3+ or FISH（+） * clear hormone receptor（HR） status * Eastern cooperative oncology group(ECOG)=0/1 * LVEF≥55% * pathologic grading of Miller and Payne * screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ULM,Aspartate transaminase (AST)/ALT≤2.5×ULM,platelet≥80000/mm3，serum creatinine≤1.5×ULM * no pregnant or nursing * signed Informed consent forms
Exclusion criteria
* prior exposure to any treatments for breast cancer * inflammatory/Bilateral/IV stage breast cancer * poor physical condition * pregnant or nursing * Cardiac risk（Congestive heart failure、arrhythmia、myocardial infarct、Refractory hypertension（systolic pressure\>180mmHg/diastolic pressure\>100mmHg）） * any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer * Allergic to chemotherapy drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | up to one year |
Secondary
| Measure | Time frame |
|---|---|
| clinical response rate | up to one year |
| Number of Adverse Event | up to one year |
Countries
China
Contacts
Primary Contacttao wang, Ph.D
Backup Contactzefei jiang, Ph.D
Outcome results
None listed