Status:
COMPLETED
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
Lead Sponsor:
EirGenix, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuva...
Eligibility Criteria
Inclusion
- 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).
- Female, ≥18 and ≤65 years of age.
- Histologically-confirmed invasive carcinoma of the breast (American Joint Committee on Cancer \[AJCC, vs. 8.0\] Stage II, IIIa).
- Operable breast cancer, planned surgical resection of breast tumor (mastectomy or lumpectomy) and sentinel or axillary lymph nodes.
- Unilateral, measurable tumor of the breast \>2 cm in diameter.
- HER2 positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, as confirmed by central laboratory.
- Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.
- Adequate bone marrow function, defined as granulocyte count of ≥1.500/µL, and platelet count of ≥100.000/µL.
- 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
- 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.
- Hemoglobin concentrations ≥10 g/dL.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- LVEF ≥55%, measured by multiple-gated acquisition (MUGA) scan or echocardiography.
- Negative pregnancy test at entry, women of childbearing potential have to use contraceptives during the course of the study.
- Females with childbearing potential must provide a negative serum pregnancy test at Screening and must be using adequate birth control. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 7 months after study drug treatment. These methods include hormonal contraceptives, intrauterine device, or double barrier contraception (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 surgical sterilization or hysterectomy at least 3 months before study start.
- Exclusion Criteria:
- Bilateral breast cancer.
- Pregnancy or lactation or considering becoming pregnant.
- Metastases, other than sentinel/axillary lymph nodes.
- Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for invasive malignant disease or other concomitant malignancy, other than basal cell carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed.
- Previous treatment with Herceptin.
- 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; hemodynamic effective pericardial effusion; other cardiomyopathies; LVEF of \<55%.
- 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.
- Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
- History of, or known current problems with, drug or alcohol abuse.
- Other serious illness, medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.
Exclusion
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT03433313
Start Date
October 16 2018
End Date
January 20 2022
Last Update
January 20 2023
Active Locations (91)
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1
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
2
Aultman Hospital, Cancer Center
Canton, Ohio, United States, 44718
3
Brest Regional Oncology Center
Brest, Belarus
4
Gomel Regional Clinical Oncology Center
Homyel, Belarus