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

Inclusion Criteria:

1. Provide signed and dated written informed consent before entering the study. The
informed consent will cover both parts of the study (neoadjuvant part and adjuvant
part).

2. Female, ≥18 and ≤65 years of age.

3. Histologically-confirmed invasive carcinoma of the breast

4. Operable breast cancer, planned surgical resection of breast tumor (mastectomy or
lumpectomy) and sentinel or axillary lymph nodes.

5. Ipsilateral, measurable tumor of the breast ≥2 cm in diameter.

6. HER2 positive tumor

7. Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.

8. Adequate bone marrow function

9. Adequate hepatic and renal function

10. International normalized ratio ≤1.5×ULN (2 to 3×ULN if on anticoagulants) or
prothrombin time ≤1.5×ULN; activated partial thromboplastin time ≤1.5×ULN.

11. Hemoglobin concentrations within the normal ranges.

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 use
contraceptives during the course of the study.

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) for
invasive malignant disease or other concomitant active malignancy, other than basal
cell carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is
allowed.

5. Other serious illness or medical disorder.

6. Previous treatment with Herceptin.

7. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension;
left ventricular hypertrophy on echocardiography; history of myocardial infarction or
cardiac failure, New York Heart Association (NYHA) class II or higher; clinically
significant cardiac valvular disease; hemodynamic effective pericardial effusion;
other cardiomyopathies; coronary artery disease; LVEF of <55%.

8. Any investigational treatment less than 30 days prior to study entry, or within a time
interval less than at least 5 half-lives of the investigational medicinal product,
whichever is longer.

9. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or
human immunodeficiency virus (HIV).

10. History of hypersensitivity to the study drug or to drugs with similar chemical
structures.

11. History of, or known current problems with, drug or alcohol abuse.

12. Other serious illness, medical disorder or condition that, in the opinion of the
Investigator, would make the patient unsuitable for participation in the study.