biosafety assesment of aryogen company trustuzumab (™Hersease) in breast cancer
Phase 3
- Conditions
- Benign neoplasm of breast.Benign neoplasm of connective tissues and soft parts of breast
- Registration Number
- IRCT2015090621315N2
- Lead Sponsor
- Aryogene pharmed company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
inclusion criteria: female aged 18- 70 years at the time of signing the informed consent form; HER2+ breast cancer in ich experiment with 3+ and or 2+ that has reported positive by FISH method; ECOG grade between 0-1; LVEF 55% or more.
exclusion criteria: bilateral metastatic breast cancer; other malignancies; renal, liver, bone marrow and cardiac insufficiencies; hypertention; pregnancy or planning to be pregnant.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of drug related adverse effects. Timepoint: after each 3 weeks period of recieving chemotherapy regimen. Method of measurement: physical examination.;Information about all advers drug reaction, adverse effects and clinical information. Timepoint: after each 3 weeks period of recieving chemotherapy regimen and exactly befor recieving next regimen. Method of measurement: physical examination.
- Secondary Outcome Measures
Name Time Method Blood tests include: hemoglobin, Diff and total RBC, WBC and platelets count, liver function tests include ALT, AST, bilirubin and alkaline phosphatase. Timepoint: after each 3 weeks period of recieving chemotherapy regimen. Method of measurement: blood test.;Assessment of cardiac arrhythmia. Timepoint: after each 3 weeks period of recieving chemotherapy regimen. Method of measurement: electrocardiography.;Assessment of Left Ventricular Ejection Fraction. Timepoint: after each 3 weeks period of recieving chemotherapy regimen. Method of measurement: echocardiography.;ECOG grade. Timepoint: after each 3 weeks period of recieving chemotherapy regimen. Method of measurement: physical examination.