Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.

Detailed Description
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Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated. Anthracycline-based regimen (d1, q3w): EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2) Nab-paclitaxel 260mg/m2 (d1, q3w) Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.

Official Title
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Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer

Conditions
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Breast Cancer, HER-2 Positive Breast Cancer, Effects of Chemotherapy

Intervention / Treatment
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* Drug: Nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed invasive breast cancer T1c-3 N0-2a Confirmed of hormonal receptor status HER2 positive confirmed by IHC 3+ or FISH+ LVEF > 50% by echocardiogram or MUGA Adequate EKG No prior treatment for breast cancer PS 0-1 Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl Written informed consent Exclusion Criteria: With history of hypersensitivity reaction for important drug in this study With history of invasive breast cancer Bilateral invasive breast cancer Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus Positive for HBs antigen and with history of HVB With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension With severe edema With severe peripheral neuropathy With severe psychiatric disorder Pregnant or nursing women Cases who physician judged improper to entry this trial

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel<br>Nab-paclitaxel q3w 260mg/m2 | Drug: Nab-paclitaxel<br>* Nab-paclitaxel 260mg/m2 q3w<br>* Other names: Abraxane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pathological complete response rate |  | 1 year from last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 5 years from the last patient enrolled | 
| Overall response rate |  | After the protocol therapy | 
| Pathological response rate |  | After the protocol therapy | 
| Breast-conserving surgery rate |  | After the protocol therapy | 
| Safety |  | Within the protocol thepapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trastuzumab, Neoadjuvant chemotherapy, Primary chemotherapy