1. Home
  2. Approved trials
  3. » فارسی

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

Summary
purpose: evaluation of aryogen trastuzumab biosafety. design: A randomized clinical trial to evaluate biosafety of trastuzumab produced by aryogen (™Hercease) in comparison to ™Herceptin. setting and conduct: first all staff will be educated through conducting the trial and then patient assessment will be held by surgeon. after introducing patients, Filing, assining the 6 digit code to every patient and giving it to pharmacist to determine the intervention group will be done. eligible patients will be treated by chemotherapy 12 weeks after breast surgery. inclusion criteria: female with age between 18 - 70 years; HER2+ breast cancer. exclusion criteria: bilateral metastatic breast cancer; other malignancies; renal, liver and bone marrow insufficiency; intervention time: from April 26, 2014 up to 1 year. chemotherapy regimen: first we inject Docetaxel (100mg/m2) in days 1,22 and 43. also infusion of trastuzumab (4mg/kg) as loading dose at first day and 2mg/kg as maintenance dose in days 8, 15, 22, 29, 36, 43, 50 and 57 via IV route. after that in 3 periods with 3 weeks interval we will infuse 5FU 600mg/m2, Cyclophosphamide 600mg/m2 and Epirubicin 60mg/m2 at first day of each interval. patients in control group will recieve the same regimen in test group but with trastuzumab of aryogen. primary outcome measures include incidence of drug related adverse effects, and clinical information. secondary outcomes include: ECOG grade, blood test for evaluation of blood factors and EEG for assessment of cardiac arrhythmia.

General information

Acronym
TRA.ARY.KM.92
IRCT registration information
IRCT registration number: IRCT2015090621315N2
Registration date: 2015-10-14, 1394/07/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-14, 1394/07/22
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
Aryogen pharmaceutical company
Expected recruitment start date
2014-04-26, 1393/02/06
Expected recruitment end date
2015-04-26, 1394/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized, double blind clinical trial to evaluate biosafety of trastuzumab produced by aryogen company (™Hercease) in comparison to Roche company trastuzumab (™Herceptin)
Public title
biosafety assesment of aryogen company trustuzumab (™Hersease) in breast cancer
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization method: balanced block randomization with concealment

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of jihad-e-daneshgahi breast cancer institute
Street address
NO45- west shahid nazari st- aboureyhan st- enghelab e eslami st
City
Tehran
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.ACECR.IBCRC.REC.1394.3

2

Ethics committee
Name of ethics committee
Isfahan university of medical science, Medical Ethics Committee
Street address
:International Bureau, Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran, 81746 73461
City
Esfahan
Postal code
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.MUI.REC.1395.04.041

Health conditions studied

1

Description of health condition studied
Benign neoplasm of breast
ICD-10 code
D24
ICD-10 code description
Benign neoplasm of connective tissues and soft parts of breast

Primary outcomes

1

Description
incidence of drug related adverse effects
Timepoint
after each 3 weeks period of recieving chemotherapy regimen
Method of measurement
physical examination

2

Description
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 outcomes

1

Description
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

2

Description
assessment of cardiac arrhythmia
Timepoint
after each 3 weeks period of recieving chemotherapy regimen
Method of measurement
electrocardiography

3

Description
Assessment of Left Ventricular Ejection Fraction
Timepoint
after each 3 weeks period of recieving chemotherapy regimen
Method of measurement
echocardiography

4

Description
ECOG grade
Timepoint
after each 3 weeks period of recieving chemotherapy regimen
Method of measurement
physical examination

Intervention groups

1

Description
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, 43, 50 and 57 via IV route. after that in 3 periods with 3 weeks interval we will infuse 5FU 600mg/m2, Cyclophosphamide 600mg/m2 and Epirubicin 60mg/m2 at first day of each interval.
Category
Treatment - Drugs

2

Description
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, 36, 43, 50 and 57 via IV route. after that in 3 periods with 3 weeks interval we will infuse 5FU 600mg/m2, Cyclophosphamide 600mg/m2 and Epirubicin 60mg/m2 at first day of each interval.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahad daneshgahi center
Full name of responsible person
Safa Najjar Najafi
Street address
Molla sadra street, Tehran, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Firozgar Hospital
Full name of responsible person
Mohsen Razavi
Street address
Valiasr Street, Valadi Street, Tehran, Iran
City
Tehran

3

Recruitment center
Name of recruitment center
Emam khomini Hospital
Full name of responsible person
Seyed Reza Safaeinodehi, Farhad Shahi, Sanambar Sadighi, Mohammad Esfandbod, Seyed Amir Hossein Emam
Street address
Keshavarz Blvd., Tehran, Iran
City
Tehran

4

Recruitment center
Name of recruitment center
501 Artesh Hospital
Full name of responsible person
Mohsen Rajaeinejad
Street address
Etemadzadeh St.,Dr.Fatemi Ave. 10000 Tehran Iran
City
Tehran

5

Recruitment center
Name of recruitment center
Booali Hospital
Full name of responsible person
Arash Jenabian
Street address
Imam Hossein Square, Beginning Damavand Avenue, Tehran, Iran
City
Tehran

6

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Mojtaba Ghadyani
Street address
Tabnak St., Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran

7

Recruitment center
Name of recruitment center
Mehrad Hospital
Full name of responsible person
Jahangir Raafat
Street address
Mir Emad St.,Tehran, Iran
City
Tehran

8

Recruitment center
Name of recruitment center
Masud clinic
Full name of responsible person
Masoud Iravani
Street address
19th street. Amirabad. Tehran Iran
City
Tehran

9

Recruitment center
Name of recruitment center
Toos Hospital
Full name of responsible person
Saeed Salimie
Street address
Ebadi street, Tehran, Iran
City
Tehran

10

Recruitment center
Name of recruitment center
Hazrate Rasool
Full name of responsible person
Nafiseh Ansari nejhad
Street address
Niyayesh St., Satarkhan St., Tehran, Iran
City
Tehran

11

Recruitment center
Name of recruitment center
Alzahra clinic
Full name of responsible person
Abbas Hajiqolami
Street address
Sheikh mofis St. Alzahra clinic, Isfahan, Iran
City
Esfahan

12

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mohammad Seghatoleslami, Mehran Hosseinzadeh, Ahmad Ahmad Zadeh
Street address
Ahvaz, Khuzestan, Iran
City
Ahvaz

13

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Mani Ramzi, Alireza Rezvani
Street address
Zand Street, Namaz Square, Shiraz, Fars, Iran
City
Shiraz

14

Recruitment center
Name of recruitment center
Shahid faqihi Hospital
Full name of responsible person
Shirin Haqiqat joo
Street address
Fars Province, Shiraz, District 6, Chamran Blvd
City
Shiraz

15

Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Bahjat Kalantari, Vahid Moazed
Street address
Kerman street century martyr, Kerman, Iran
City
Kerman

16

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Mehrdad Payandeh
Street address
Martyr Beheshti Blvd., Kermanshah, Iran
City
Kermanshah

17

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Abolghasem Allahyari
Street address
Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad

18

Recruitment center
Name of recruitment center
Seyedshohada Hospital
Full name of responsible person
Mohammad Reza Mortazavi Zade
Street address
Imam St., Yazd
City
Yazd

19

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Behrooz Najafi, Siroos Qarib, Hossein Mirpoor
Street address
Sardar jangal, Rasht, Iran
City
Rasht

20

Recruitment center
Name of recruitment center
Hazrate Rasool
Full name of responsible person
Mahdi Mirbolouk
Street address
Imam khomeinim Blvd, Rasht, Iran
City
Rasht

21

Recruitment center
Name of recruitment center
Al iebn Abitaleb Hospital
Full name of responsible person
Mahdi Hashemi
Street address
Dr. hesabi sq. Salamat Blvd, Zahedan, Iran
City
Zahedan

22

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Bayazid Qaderi
Street address
Pataran Ave., Sanandaj, Iran
City
Sanandaj

23

Recruitment center
Name of recruitment center
Immam Khomeini Hospital
Full name of responsible person
Abolqasem Janbabaie, Ramin Shekarriz, Mohammad islami, Ehsan Zaboli
Street address
Imam Ave., Jooybar Blvd, Sari, Iran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Aryogene pharmed company
Full name of responsible person
Somayeh Amini
Street address
Orchid Pharmed No 2, Khorasani deadend, Derakhti St, Dadman St, Shahrak-eGharb
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aryogene pharmed company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Orchid Pharmed Company
Full name of responsible person
Ramin Azhdarazadeh
Position
Pharmacist (PharmD), Clinical Trial Manager
Other areas of specialty/work
Street address
No 10, Ninth street, Iranzamin Blvd, Shahrak-e-Gharb
City
Tehran
Postal code
1465884171
Phone
+98 21 8808 8821
Fax
Email
No.2, khorasani Alley, Derakhti Ave, dadman blvd, Shahrak-e-Gharb Tehran Tehran Iran, Islamic Rep
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
jihad-e-daneshgahi breast cancer institute
Full name of responsible person
Dr keivan majidzadeh
Position
PHD of medical biotechnology
Other areas of specialty/work
Street address
NO45- west shahid nazari st- aboureyhan st- enghelab e eslami st
City
tehran
Postal code
1315893111
Phone
+98 21 6648 0877
Fax
+98 21 6695 2040
Email
kmajidzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Orchid Pharmed Company
Full name of responsible person
Somayeh Amini
Position
Pharmacist (PharmD), Medical Manager
Other areas of specialty/work
Street address
No 10, Ninth street, Iranzamin Blvd, Shahrak-e-Gharb
City
tehran
Postal code
1465884171
Phone
+98 21 8807 5724
Fax
Email
amini.s@orchidpharmed.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...