A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer

Study Overview
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Brief Summary
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The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.

Official Title
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A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)

Conditions
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Stage III Breast Cancer

Intervention / Treatment
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* Drug: docetaxel, epirubicin and cyclophosphamide
* Drug: docetaxel, epirubicin and cyclophosphamide plus endostar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis) Age 18-70 No evidence of distant metastasis No previous therapy Normal hematologic function No abnormality of renal or liver function Written informed consent Exclusion Criteria: With allergic constitution or possible allergic reflection to drugs to be used in this study Any concurrent uncontrolled medical or psychiatric disorder History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease Being pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Chemo plus Endostar<br>Docetaxel, epirubicin and cyclophosphamide plus endostar | Drug: docetaxel, epirubicin and cyclophosphamide plus endostar<br>* docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles<br>|
| Active Comparator: Chemo only<br>docetaxel, epirubicin and cyclophosphamide | Drug: docetaxel, epirubicin and cyclophosphamide<br>* docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical/pathological response | The clincial response will be evaluated according to RECIST criteria. | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 5 years |