Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer

1. Provide signed and dated written informed consent before entering the study. Theinformed consent will cover both parts of the study (neoadjuvant part and adjuvantpart).
2. Female, ≥18 and ≤65 years of age.
3. Histologically-confirmed invasive carcinoma of the breast (American Joint Committee onCancer [AJCC, vs. 8.0] Stage II, IIIa).
4. Operable breast cancer, planned surgical resection of breast tumor (mastectomy orlumpectomy) and sentinel or axillary lymph nodes.
5. Unilateral, measurable tumor of the breast >2 cm in diameter.
6. HER2 positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, asconfirmed by central laboratory.
7. Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.
8. Adequate bone marrow function, defined as granulocyte count of ≥1.500/µL, and plateletcount of ≥100.000/µL.
9. Adequate hepatic and renal function, defined as: bilirubin within normal range alanine aminotransferase (ALT) ≤2 x upper limit of normal (ULN) aspartate aminotransferase (AST) ≤2 x ULN gamma glutamyl transferase (GGT) ≤3 x ULN serum creatinine <1.5 ULN
10. International normalized ratio ≤1.5×ULN (2 to 3×ULN if on anticoagulants) orprothrombin time ≤1.5×ULN; activated partial thromboplastin time ≤1.5×ULN.
11. Hemoglobin concentrations ≥10 g/dL.
12. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
13. LVEF ≥55%, measured by multiple-gated acquisition (MUGA) scan or echocardiography.
14. Negative pregnancy test at entry, women of childbearing potential have to usecontraceptives during the course of the study. Females with childbearing potential must provide a negative serum pregnancy test atScreening and must be using adequate birth control. Adequate birth control is defined asagreement to consistently practice an effective and accepted method of contraceptionthroughout the duration of the study and for 7 months after study drug treatment. Thesemethods include hormonal contraceptives, intrauterine device, or double barriercontraception (i.e., condom + diaphragm) or a male partner with documented vasectomy. Non-childbearing potential is defined as post-menopausal for at least 1 year or surgicalsterilization or hysterectomy at least 3 months before study start.

Exclusion Criteria:

1. Bilateral breast cancer.
2. Pregnancy or lactation or considering becoming pregnant.
3. Metastases, other than sentinel/axillary lymph nodes.
4. Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) forinvasive malignant disease or other concomitant malignancy, other than basal cellcarcinoma of the skin. Previous treatment for carcinoma in situ of the cervix isallowed.
5. Previous treatment with Herceptin.
6. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension;history of myocardial infarction or cardiac failure, New York Heart Association (NYHA)class II or higher; clinically significant cardiac valvular disease; hemodynamiceffective pericardial effusion; other cardiomyopathies; LVEF of <55%.
7. Any investigational treatment less than 30 days prior to study entry, or within a timeinterval less than at least 5 half-lives of the investigational medicinal product,whichever is longer.
8. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), orhuman immunodeficiency virus (HIV).
9. History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
10. History of, or known current problems with, drug or alcohol abuse.
11. Other serious illness, medical disorder or condition that, in the opinion of theInvestigator, would make the patient unsuitable for participation in the study.