CTRI/2018/09/015794进行中（未招募）3 期
Phase III, Randomized, Multicenter, Double-blind study to compare efficacy and safety of EG12014 (Eirgenix Trastuzumab) with Herceptin® as Neoadjuvant treatment in combination with Anthracycline/Paclitaxel-based systemic therapy in patients with HER2-positive Early breast cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Eirgenix Inc
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients will be entered into this study only if they meet all of the following 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
- •2. Female, >=18 and <=65 years of age.
- •3. Histologically-confirmed invasive carcinoma of the breast (American Joint
- •Committee on Cancer [AJCC] Stage II, IIIa [43]).
- •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, defined as 3+ score by IHC or fluorescence positive by FISH.
- •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
- •platelet count 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 mg/dL
- •10. International normalized ratio <=1.5Ã?ULN (2 to 3Ã?ULN if on anticoagulants) or
- •prothrombin time <=1.5Ã?ULN; activated partial thromboplastin time <=1.5Ã?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.
- •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 6 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.
- •4.2 Inclusion Criterion after Surgery (Adjuvant Part of the Study)
- •After completion of the neoadjuvant part of the study and surgery, patients will be
- •eligible for double-blind adjuvant therapy with EG12014 or Herceptin if they meet the
- •following criterion:
- •1. No sequelae have occurred after neoadjuvant therapy, in particular regarding cardiac
- •function. No separate informed consent is required.
排除标准
- •Patients will be entered into this study only if they meet none of the following 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.
研究者
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