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

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.