A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs

Study Overview
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Brief Summary
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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

Official Title
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A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Epirubicin
* Drug: Docetaxel
* Drug: Trastuzumab
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group<br>docetaxel+carboplatin+trastuzumab | Drug: Docetaxel<br>* 75mg/m2 d1 evry 21days<br>* Other names: Taxotere;Drug: Trastuzumab<br>* 6mg/kg(loading dosage is 8mg/kg)<br>* Other names: Herceptin;Drug: Carboplatin<br>* Area Under Curve(AUC)=6 d1 evry 21days<br>* Other names: Paraplatin;|
| Active Comparator: B group<br>Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab | Drug: Epirubicin<br>* 75mg/m2 d1 evry 21days<br>* Other names: pharmorubicin;Drug: Docetaxel<br>* 75mg/m2 d1 evry 21days<br>* Other names: Taxotere;Drug: Trastuzumab<br>* 6mg/kg(loading dosage is 8mg/kg)<br>* Other names: Herceptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response rate |  | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response rate |  | up to one year | 
| Number of Adverse Event |  | up to one year |