Last updated on April 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: Between 18 - 65 Years
  • Gender: Female

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 1.5ULN (2 to 3ULN if on anticoagulants) or prothrombin time 1.5ULN; activated partial thromboplastin time 1.5ULN.
  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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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