EUCTR2016-000206-10-PL进行中（未招募）1 期
Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin® in Previously Untreated HER2 Overexpressing Metastatic Breast Cancer
Shanghai Henlius Biotech Inc.0 个研究点目标入组 608 人开始时间: 2017年4月27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
- 608
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
- All
入选标准
- •Voluntarily agreed to participate and given written informed consent
- •Male or female =18 years of age on day of signing the informed consent form
- •Histologically or cytologically confirmed adenocarcinoma of the breast
- •Recurrent disease not amenable to curative surgery or radiation therapy, or metastatic disease with an indication for a taxane-containing therapy
- •Availability of formalin-fixed paraffin-embedded tissue block from the primary tumor, or a metastatic lesion, to confirm HER2-positivity by the central laboratory, based on FISH amplification ratio =2.0 or IHC score 3+, and for hormone status (ER/PgR) determination (local or central laboratory). If not possible, a fresh biopsy is required
- •No prior systemic anticancer agent such as chemotherapy, biological or targeted agent for metastatic disease with the exception of hormonal therapy.
- •For patients with recurrent disease, prior neo-/adjuvant therapy containing trastuzumab and/or lapatinib must have been stopped at least 12 months before the diagnosis of recurrent (local or metastatic) disease (i.e. a disease free interval of =12 months). If trastuzumab /lapatinib was not used, prior neo-/adjuvant therapy with a taxane must have been stopped at least 6 months before the diagnosis of recurrent (local or metastatic) disease (i.e. a disease free interval of =6 months). If only other cytotoxics were given, they must be stopped at least 4 weeks before randomization. Any hormonal therapy must be stopped at the time of the ICF signature (at least 2 weeks before randomization)
- •Measurable disease
- •Eastern Cooperative Oncology Group performance status of 0-1
- •Left ventricular ejection fraction (LVEF) within institutional range of normal at baseline (within 42 days before randomization) as determined by either echocardiography (ECHO) or multigated acquisition (MUGA) scan
- •Adequate hematologic, hepatic and renal function
- •Estimated life expectancy =3 months
- •Female patients are eligible to enter and participate in the study if they are of:
- •- Non-childbearing potential
- •- Childbearing potential, have a negative serum pregnancy test at Screening, are not breast feeding, and use highly-effective or acceptable contraceptive measures before study entry and throughout the study until 7 months after the last investigational/comparator product administration.
- •Male patients with partners of childbearing potential are eligible to enter and participate in the study if they are willing to use highly-effective or acceptable contraceptive measures before study entry and
- •throughout the study until 7 months after the last IP/comparator administration
- •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 516
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 91
排除标准
- •Previously- or currently-treated metastatic breast cancer with the exception of hormonal therapy
- •Known brain metastasis or other Central nervous system (CNS) metastasis that is either symptomatic or untreated. CNS metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomography (CT) scan for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants
- •Underlying medical conditions or current severe, uncontrolled systemic disease that, in the Investigator’s opinion, will make the administration of study drug hazardous. A major surgical procedure within 4 weeks prior to enrolment or anticipation of the need for major surgery during the course of study
- •Current uncontrolled hypertension or unstable angina
- •History of chronic heart failure of any New York Heart Association criteria, or left ventricular hypertrophy. Current serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia) or clinically significant conduction defects as seen on electrocardiogram. History of myocardial infarction within 6 months of randomization. History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy. Significant cardiac murmurs either on examination or ECHO
- •History of prior exposure to doxorubicin >360 mg/m² (or equivalent)
- •Use of oral, injected or implanted hormonal methods of contraception
- •Known hypersensitivity to any of the study drugs
- •Residual non-hematologic toxicity = Grade 2 from prior therapy
研究者
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