Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

Key Inclusion Criteria: * Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria). * Available tumor tissue for central review of HER2 status. * Planned surgical resection of breast tumor. * Planned neoadjuvant chemotherapy. * Documentation of HER2 gene amplification or overexpression. * Ipsilateral, measurable tumor longest diameter \> 2 cm. * Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening). * ECOG performance status of 0 or 1. * Adequate bone marrow, hepatic and renal functions. * Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan. * Effective contraception as defined by protocol. Key Exclusion Criteria: * Investigational therapy within 2 months of first dose of study drug. * Bilateral breast cancer. * Inflammatory breast cancer * Metastases. * Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer. * Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug. * Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension. * Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug. * Pre-existing clinically significant Grade 2 peripheral neuropathy. * Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer). * Severe dyspnea at rest requiring oxygen therapy. * Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C. * Current pregnancy or breastfeeding. * Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.