Clinical Trial Protocol Iranian Registry of Clinical Trials 02 Oct 2021 A randomized, double blind clinical trial to evaluate biosafety of trastuzumab produced by aryogen company (™Hercease) in comparison to Roche company trastuzumab (™Herceptin) Protocol summary Registration date: 2015-10-14, 1394/07/22 Registration timing: retrospective Summary purpose: evaluation of aryogen trastuzumab biosafety. design: A randomized clinical trial to evaluate biosafety Last update: of trastuzumab produced by aryogen (™Hercease) in Update count: 0 comparison to ™Herceptin. setting and conduct: first all Registration date staff will be educated through conducting the trial and 2015-10-14, 1394/07/22 then patient assessment will be held by surgeon. after Registrant information introducing patients, Filing, assining the 6 digit code to Name every patient and giving it to pharmacist to determine Nassim Anjidani the intervention group will be done. eligible patients will Name of organization / entity be treated by chemotherapy 12 weeks after breast Orchid Pharmed surgery. inclusion criteria: female with age between 18 - Country 70 years; HER2+ breast cancer. exclusion criteria: Iran (Islamic Republic of) bilateral metastatic breast cancer; other malignancies; Phone renal, liver and bone marrow insufficiency; intervention +98 21 4347 3000 time: from April 26, 2014 up to 1 year. chemotherapy Email address regimen: first we inject Docetaxel (100mg/m2) in days [email protected] 1,22 and 43. also infusion of trastuzumab (4mg/kg) as loading dose at first day and 2mg/kg as maintenance Recruitment status dose in days 8, 15, 22, 29, 36, 43, 50 and 57 via IV route. Recruitment complete after that in 3 periods with 3 weeks interval we will Funding source infuse 5FU 600mg/m2, Cyclophosphamide 600mg/m2 Aryogen pharmaceutical company and Epirubicin 60mg/m2 at first day of each interval. patients in control group will recieve the same regimen Expected recruitment start date in test group but with trastuzumab of aryogen. primary 2014-04-26, 1393/02/06 outcome measures include incidence of drug related Expected recruitment end date adverse effects, and clinical information. secondary 2015-04-26, 1394/02/06 outcomes include: ECOG grade, blood test for evaluation Actual recruitment start date of blood factors and EEG for assessment of cardiac empty arrhythmia. Actual recruitment end date empty General information Trial completion date empty Acronym TRA.ARY.KM.92 Scientific title IRCT registration information A randomized, double blind clinical trial to evaluate IRCT registration number: IRCT2015090621315N2 biosafety of trastuzumab produced by aryogen company 1 (™Hercease) in comparison to Roche company IR.ACECR.IBCRC.REC.1394.3 trastuzumab (™Herceptin) Public title 2 biosafety assesment of aryogen company trustuzumab Ethics committee (™Hersease) in breast cancer Name of ethics committee Purpose Isfahan university of medical science, Medical Ethics Treatment Committee Inclusion/Exclusion criteria Street address inclusion criteria: female aged 18- 70 years at the time of :International Bureau, Isfahan University of Medical signing the informed consent form; HER2+ breast cancer Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR in ich experiment with 3+ and or 2+ that has reported Iran, 81746 73461 positive by FISH method; ECOG grade between 0-1; LVEF City 55% or more. exclusion criteria: bilateral metastatic Esfahan breast cancer; other malignancies; renal, liver, bone Postal code marrow and cardiac insufficiencies; hypertention; Approval date pregnancy or planning to be pregnant. 2016-07-17, 1395/04/27 Age Ethics committee reference number From 18 years old to 70 years old IR.MUI.REC.1395.04.041 Gender Female Health conditions studied Phase 3 1 Groups that have been masked No information Description of health condition studied Sample size Benign neoplasm of breast Target sample size: 20 ICD-10 code Randomization (investigator's opinion) D24 Randomized ICD-10 code description Randomization description Benign neoplasm of connective tissues and soft parts of Blinding (investigator's opinion) breast Double blinded Blinding description Primary outcomes Placebo Not used 1 Assignment Parallel Description Other design features incidence of drug related adverse effects randomization method: balanced block randomization Timepoint with concealment after each 3 weeks period of recieving chemotherapy regimen Secondary Ids Method of measurement physical examination empty 2 Ethics committees Description information about all advers drug reaction, adverse 1 effects and clinical information Ethics committee Timepoint Name of ethics committee after each 3 weeks period of recieving chemotherapy ethics committee of jihad-e-daneshgahi breast cancer regimen and exactly befor recieving next regimen institute Method of measurement Street address physical examination NO45- west shahid nazari st- aboureyhan st- enghelab e eslami st Secondary outcomes City Tehran Postal code 1 Approval date Description 2015-08-23, 1394/06/01 blood tests include: hemoglobin, Diff and total RBC, WBC Ethics committee reference number and platelets count, liver function tests include ALT, AST, 2 bilirubin and alkaline phosphatase Category Timepoint Treatment - Drugs after each 3 weeks period of recieving chemotherapy regimen Recruitment centers Method of measurement blood test 1 2 Recruitment center Name of recruitment center Description Jahad daneshgahi center assessment of cardiac arrhythmia Full name of responsible person Timepoint Safa Najjar Najafi after each 3 weeks period of recieving chemotherapy Street address regimen Molla sadra street, Tehran, Iran Method of measurement City electrocardiography Tehran 3 2 Description Recruitment center Assessment of Left Ventricular Ejection Fraction Name of recruitment center Timepoint Firozgar Hospital after each 3 weeks period of recieving chemotherapy Full name of responsible person regimen Mohsen Razavi Method of measurement Street address echocardiography Valiasr Street, Valadi Street, Tehran, Iran City 4 Tehran Description ECOG grade 3 Timepoint Recruitment center after each 3 weeks period of recieving chemotherapy Name of recruitment center regimen Emam khomini Hospital Method of measurement Full name of responsible person physical examination Seyed Reza Safaeinodehi, Farhad Shahi, Sanambar Sadighi, Mohammad Esfandbod, Seyed Amir Hossein Intervention groups Emam Street address 1 Keshavarz Blvd., Tehran, Iran City Description Tehran Patients in control group at first will receive Docetaxel (100mg/m2) in days 1,22 and 43. also infusion of Roche 4 trastuzumab (Herceptin) (4mg/kg) as loading dose and 2mg/kg in days 8, 15, 22, 29, 36, 43, 50 and 57 via IV Recruitment center route. after that in 3 periods with 3 weeks interval we will Name of recruitment center infuse 5FU 600mg/m2, Cyclophosphamide 600mg/m2 501 Artesh Hospital and Epirubicin 60mg/m2 at first day of each interval. Full name of responsible person Category Mohsen Rajaeinejad Treatment - Drugs Street address Etemadzadeh St.,Dr.Fatemi Ave. 10000 Tehran Iran 2 City Tehran Description Patients in intervention group at first will receive 5 Docetaxel (100mg/m2) in days 1,22 and 43. also infusion of AryoGen trastuzumab (Hercease) (4mg/kg) as loading Recruitment center dose and 2mg/kg in days 8, 15, 22, 29, 36, 43, 50 and 57 Name of recruitment center via IV route. after that in 3 periods with 3 weeks interval Booali Hospital we will infuse 5FU 600mg/m2, Cyclophosphamide Full name of responsible person 600mg/m2 and Epirubicin 60mg/m2 at first day of each Arash Jenabian interval. Street address 3 Imam Hossein Square, Beginning Damavand Avenue, City Tehran, Iran Tehran City Tehran 11 Recruitment center 6 Name of recruitment center Recruitment center Alzahra clinic Name of recruitment center Full name of responsible person Ayatollah Taleghani Hospital Abbas Hajiqolami Full name of responsible person Street address Mojtaba Ghadyani Sheikh mofis St. Alzahra clinic, Isfahan, Iran Street address City Tabnak St., Velenjak Region, Chamran High Way, Esfahan Tehran, Iran City 12 Tehran Recruitment center Name of recruitment center 7 Shafa Hospital Recruitment center Full name of responsible person Name of recruitment center Mohammad Seghatoleslami, Mehran Hosseinzadeh, Mehrad Hospital Ahmad Ahmad Zadeh Full name of responsible person Street address Jahangir Raafat Ahvaz, Khuzestan, Iran Street address City Mir Emad St.,Tehran, Iran Ahvaz City Tehran 13 Recruitment center 8 Name of recruitment center Recruitment center Namazi Hospital Name of recruitment center Full name of responsible person Masud clinic Mani Ramzi, Alireza Rezvani Full name of responsible person Street address Masoud Iravani Zand Street, Namaz Square, Shiraz, Fars, Iran Street address City 19th street. Amirabad. Tehran Iran Shiraz City Tehran 14 Recruitment center 9 Name of recruitment center Recruitment center Shahid faqihi Hospital Name of recruitment center Full name of responsible person Toos Hospital Shirin Haqiqat joo Full name of responsible person Street address Saeed Salimie Fars Province, Shiraz, District 6, Chamran Blvd Street address City Ebadi street, Tehran, Iran Shiraz City Tehran 15 Recruitment center 10 Name of recruitment center Recruitment center Bahonar Hospital Name of recruitment center Full name of responsible person Hazrate Rasool Bahjat Kalantari, Vahid Moazed Full name of responsible person Street address Nafiseh Ansari nejhad Kerman street century martyr, Kerman, Iran Street address City Niyayesh St., Satarkhan St., Tehran, Iran