A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study of AryoTrust™ (AryogenTrastuzumab) efficacy and safety in Human Epidermal Growth Factor Receptor 2–Positive breast cancer in comparison to Herceptin® (Genentech/Roche) control.

Aryogen pharmed Company0 个研究点目标入组 108 人开始时间: 待定最近更新: 2018年9月11日

适应症

试验速览

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•18-70 years old female patients
•Patients with newly diagnosed stage III(locally advanced) or in-operable stage II (due to sizes larger than 5 cm or high tumor to breast ratio) tumors are candidates for participation
•Willing and able to sign an informed consent
•Pathological diagnosis of adenocarcinoma of the breast
•ECOG status of 0-1
•With any ER/PR status
•HER2 positive

•Clinical or radiologic evidence of metastatic disease
•History of any other malignancy including previous breast cancer, second non-breast malignant disease
•History of previous chemotherapy
•Left ventricular ejection fraction [LVEF] <55% confirmed by echo cardiogram within 3 months before registration
•Any prior myocardial infarction, History of documented congestive heart failure (CHF)
•Any prior history of arrhythmia or cardiac vascular disease requiring medications or clinically significant
•Current use of medications for treatment of angina pectoris
•Current uncontrolled hypertension (diastolic > 100 mmHg or systolic > 200 mmHg)
•A severe conduction abnormality (having pacemaker or diagnosed by the ECG) and any other significant cardiovascular disease
•Hematologic abnormalities including baseline Absolute NeutrophilCount (ANC) of=1,500/µL or platelet count = 100,000/µL
•Liver dysfunction including : Alanine amino transferase(ALT) and/or aspartate amino transferase (AST) =3 Upper Limit Normal (ULN), Alkaline phosphatase (ALP) =3 ? ULN serum, total bilirubin > 1.5 ULN
•Renal dysfunction, defined as serum creatinin =2.5 mg/dL
•Pregnant, lactating women or women of childbearing potential who are not willing to use adequate contraception

发起方

Aryogen pharmed Company