Benign neoplasm of breast. Benign neoplasm of connective tissues and soft parts of breast
Conditions
Interventions
Intervention 1: Patients in control group at first will receive Docetaxel (100mg/m2) in days 1,22 and 43. also infusion of Roche trastuzumab (Herceptin) (4mg/kg) as loading dose and 2mg/kg in days 8,
Treatment - Drugs
Patients in control group at first will receive Docetaxel (100mg/m2) in days 1,22 and 43. also infusion of Roche trastuzumab (Herceptin) (4mg/kg) as loading dose and 2mg/kg in days 8, 15, 22, 29, 36,
Patients in intervention group at first will receive Docetaxel (100mg/m2) in days 1,22 and 43. also infusion of AryoGen trastuzumab (Hercease) (4mg/kg) as loading dose and 2mg/kg in days 8, 15, 22, 29
Sponsors
Aryogene pharmed company
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRamin Azhdarazadeh
Orchid Pharmed Company
Outcome results
None listed