Efficacy and safety in AryoTrust™ (Aryogen trastuzumab) vs Herceptin® (Genentech/Roche trastuzumab), a non inferiority trial
- Conditions
- breast cancer patients with HER2-positive.Malignant neoplasm of breast
- Registration Number
- IRCT201606226135N7
- Lead Sponsor
- Aryogen pharmed Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 108
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathologic Complete Response (pCR). Timepoint: following completion of neoadjuvant systemic therapy. Method of measurement: the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes.
- Secondary Outcome Measures
Name Time Method