Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.

Official Title
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Phase II Study of Neoadjuvant Nab-paclitaxel (PTX) and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

Conditions
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Breast Cancer, Estrogen Receptor Negative Neoplasm, HER-2 Positive Breast Cancer

Intervention / Treatment
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* Drug: nab-paclitaxel
* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed invasive breast cancer Tumor size of 3cm or less and N0 Hormone receptors have been identified as negative 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 or HCV antibody 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 The case that is judged to be unsuitable for this study by physician

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 plus trastuzumab<br>Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor. | Drug: nab-paclitaxel<br>* nab-paclitaxel 260mg/m2 q3w<br>* Other names: Abraxane;Drug: Trastuzumab<br>* trastuzumab 6 mg/kg (8 mg/kg as the loading dose)<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 12 weeks after the protocol therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | Five years after the last patient enrolled | 
| Objective response rate |  | Up to 6 weeks after the protocol therapy | 
| Pathological response rate |  | Up to 12 weeks after the protocol therapy | 
| Breast-conserving surgery rate |  | Up to 6 weeks after the protocol therapy | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | Up to 6 weeks after the protocol therapy |