EUCTR2012-004319-29-IT进行中（未招募）1 期
A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared with Trastuzumab in Subjects with HER2 Positive Early Breast Cancer - Not Applicable
Amgen Inc.0 个研究点目标入组 725 人开始时间: 2013年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 725
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Females = 18 years of age
- •Histologically confirmed invasive breast cancer
- •Planning for surgical resection of breast tumor and sentinel node (SN) or axillary lymph node resection
- •Planning neoadjuvant chemotherapy
- •HER2 positive disease defined as:
- •3+ overexpression by immunohistochemistry (IHC) or
- •HER2 amplification by fluorescence in situ hybridization (FISH)
- •Measurable disease (assessment method used in order of priority: ultrasound, mammography, MRI, or physical examination) in the breast after diagnostic biopsy, defined as longest diameter = 2.0 cm
- •Known ER and PR hormone receptor status at study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Left ventricular ejection fraction (LVEF) of = 55% by 2D echocardiogram
- •Normal bone marrow function as defined by:
- •absolute neutrophil count (ANC) > 1.5 x 10^9 g/dL (1,500/µL);
- •platelets > 100 x 10^9 g/dL (100,000/µL);
- •hemoglobin > 10.0 g/dL.
- •Normal hepatic function as defined by:
- •total bilirubin within normal institutional limits;
- •aspartate aminotransferase (AST) and alanine aminotransferase (ALT);
- •< 2.5 × the upper limit of normal (ULN);
- •subjects with an elevated unconjugated bilirubin (Gilbert's syndrome) will be eligible if hepatic enzymes and function are otherwise within normal limits (ie, AST, ALT, and Alkaline Phosphatase are within normal limits), and there is no evidence of hemolysis.
- •Normal renal function as defined by creatinine < 1.5 × ULN or estimated creatinine clearance (CrCl) = 50 mL/min calculated by the Cockcroft-Gault method
- •Subjects must sign an IRB/EC-approved informed consent form before any study specific procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 445
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 111
排除标准
- •Bilateral breast cancer
- •Presence of known metastases
- •Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer
- •Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •Pre-existing clinically significant (= grade 2) peripheral neuropathy
- •Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension
- •Severe dyspnea at rest requiring supplementary oxygen therapy
- •History of positivity for hepatitis B surface antigen, hepatitis C virus, or HIV
- •Recent infection requiring a course of systemic anti-infectives that were completed
- •= 14 days before enrollment (with the exception of uncomplicated urinary tract infection)
- •Woman of childbearing potential who is pregnant or is breast feeding
- •Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) during treatment and for an additional 4 months after the last administration of the protocol specified treatment
- •Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study
- •Other investigational procedures while participating in this study are excluded
- •Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients
- •Subject previously has enrolled and/or has been randomized in this study
- •Subject likely to not be available to complete all protocol required study visits or procedures
- •History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
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