A Phase III, randomized, two armed, parallel, triple-blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) plus Trastuzumab, Carboplatin and Docetaxel compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company) plus Trastuzumab, Carboplatin and Docetaxel in neoadjuvant treatment of HER 2 positive Breast Cancer patients
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Recruitment centers
#1
Name of recruitment center - English: Emam khomini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Dr.R. Safaei, Dr.F. Shahi, Dr. S. Sadighi, Dr. M. Esfandbod, Dr. A.H. Emami
Full name of responsible person - Persian: دکتر سید رضا صفایی نودهی، دکتر فرهاد شاهی، دکتر صنمبر صدیقی، دکتر محسن اسفندبد، دکتر امیرحسین امامی
Street address - English: Keshavarz Blvd., Tehran, Iran
Street address - Persian: تهران، بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14197333141
Phone: +98 21 6658 1593
Fax:
Email: Fshahi@yahoo.com
Web page address:
Name of recruitment center - English: Emam khomini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Dr Safaei, Dr. Shahi, Dr. Sadighi, Dr. Esfandbod, Dr. Emami, Dr. Mirzania
Full name of responsible person - Persian: دکتر صفایی نودهی، دکتر شاهی، دکتر صدیقی، دکتر اسفندبد، دکتر امامی، دکتر میرزانیا
Street address - English: Keshavarz Blvd., Tehran, Iran
Street address - Persian: تهران، بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14197333141
Phone: +98 21 6658 1593
Fax:
Email: Fshahi@yahoo.com
Web page address:
Name of recruitment center - English: Emam khomini Hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: Dr.R.Dr Safaei, Dr.FDr. Shahi, Dr. S. Sadighi, Dr. M. Esfandbod, Dr. A.HEmami, Dr. EmamiMirzania Full name of responsible person - Persian: دکتر سید رضا صفایی نودهی، دکتر فرهاد شاهی، دکتر صنمبر صدیقی، دکتر محسن اسفندبد، دکتر امیرحسین امامی، دکتر میرزانیا Street address - English: Keshavarz Blvd., Tehran, Iran Street address - Persian: تهران، بلوار کشاورز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14197333141 Phone: +98 21 6658 1593 Fax: Email: Fshahi@yahoo.com Web page address:
#2
Name of recruitment center - English: Firozgar Hospital
Name of recruitment center - Persian: بیمارستان فیروز گر
Full name of responsible person - English: Dr. Mohsen Razavi
Full name of responsible person - Persian: دکتر محسن رضوی
Street address - English: Valiasr Street, Valadi Street, Tehran, Iran
Street address - Persian: تهران، میدان ولیعصر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8893 7902
Fax:
Email: s_m_raz@yahoo.com
Web page address:
Name of recruitment center - English: Firozgar Hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Dr. Mohsen Razavi, Dr. Saeed Salimi
Full name of responsible person - Persian: دکتر محسن رضوی، دکتر سعید سلیمی
Street address - English: Valiasr Street, Valadi Street, Tehran, Iran
Street address - Persian: تهران، میدان ولیعصر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8893 7902
Fax:
Email: s_m_raz@yahoo.com
Web page address:
Name of recruitment center - English: Firozgar Hospital Name of recruitment center - Persian: بیمارستان فیروز گرفیروزگر Full name of responsible person - English: Dr. Mohsen Razavi, Dr. Saeed Salimi Full name of responsible person - Persian: دکتر محسن رضوی، دکتر سعید سلیمی Street address - English: Valiasr Street, Valadi Street, Tehran, Iran Street address - Persian: تهران، میدان ولیعصر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1593747811 Phone: +98 21 8893 7902 Fax: Email: s_m_raz@yahoo.com Web page address:
#3
Name of recruitment center - English: Imam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Dr Abolqasem Allahyari, Dr Hossen Rahimi
Full name of responsible person - Persian: دکتر ابوالقاسم الهیاری، دکتر حسین الهیاری
Street address - English: Imam Reza Sq. Mashhad, Iran
Street address - Persian: مشهد، میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9137913316
Phone: +98 51 8543 0311
Fax:
Email: allahyari.abolghasem@yahoo.com
Web page address:
Name of recruitment center - English: Imam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Dr Abolqasem Allahyari
Full name of responsible person - Persian: دکتر ابوالقاسم الهیاری
Street address - English: Imam Reza Sq. Mashhad, Iran
Street address - Persian: مشهد، میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9137913316
Phone: +98 51 8543 0311
Fax:
Email: allahyari.abolghasem@yahoo.com
Web page address:
Name of recruitment center - English: Imam Reza Hospital Name of recruitment center - Persian: بیمارستان امام رضا Full name of responsible person - English: Dr Abolqasem Allahyari, Dr Hossen Rahimi Full name of responsible person - Persian: دکتر ابوالقاسم الهیاری، دکتر حسین الهیاری Street address - English: Imam Reza Sq. Mashhad, Iran Street address - Persian: مشهد، میدان امام رضا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9137913316 Phone: +98 51 8543 0311 Fax: Email: allahyari.abolghasem@yahoo.com Web page address:
#4
Name of recruitment center - English: Shafa Hospital
Name of recruitment center - Persian: بیمارستان شفا اهواز
Full name of responsible person - English: Dr. Mehran Hosseinzadeh, Dr.Ali Ehsanpour
Full name of responsible person - Persian: دکتر مهران حسین زاده -دکتر علی احسانپور
Street address - English: Ahvaz, Khuzestan, Iran
Street address - Persian: اهواز، مرکز اموزشي درماني شفا
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 3155
Phone: +98 61 1336 7543
Fax:
Email: drehsanpour@gmail.com
Web page address:
Name of recruitment center - English: Shafa Hospital
Name of recruitment center - Persian: بیمارستان شفا اهواز
Full name of responsible person - English: Dr. Mehran Hosseinzadeh, Dr Ahmad Ahmadzadeh
Full name of responsible person - Persian: دکتر مهران حسین زاده، دکتر احمد احمدزاده
Street address - English: Ahvaz, Khuzestan, Iran
Street address - Persian: اهواز، مرکز اموزشي درماني شفا
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 3155
Phone: +98 61 1336 7543
Fax:
Email: hoseinzadehmehran@gmail.com
Web page address:
Name of recruitment center - English: Shafa Hospital Name of recruitment center - Persian: بیمارستان شفا اهواز Full name of responsible person - English: Dr. Mehran Hosseinzadeh, Dr.Ali EhsanpourDr Ahmad Ahmadzadeh Full name of responsible person - Persian: دکتر مهران حسین زاده -، دکتر علی احسانپوراحمد احمدزاده Street address - English: Ahvaz, Khuzestan, Iran Street address - Persian: اهواز، مرکز اموزشي درماني شفا City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 3155 Phone: +98 61 1336 7543 Fax: Email: drehsanpourhoseinzadehmehran@gmail.com Web page address:
#5
Name of recruitment center - English: Qaem Hospital
Name of recruitment center - Persian: بیمارستان قائم
Full name of responsible person - English: Dr Alireza Bari
Full name of responsible person - Persian: دکتر علیرضا باری
Street address - English: Ahmad-Abad Street, Mashhad
Street address - Persian: مشهد، خیابان احمد آباد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 99199-91766
Phone: +98 51 3840 0000
Fax:
Email: dr.alireza.baari@gmail.com
Web page address:
Name of recruitment center - English: Qaem Hospital Name of recruitment center - Persian: بیمارستان قائم Full name of responsible person - English: Dr Alireza Bari Full name of responsible person - Persian: دکتر علیرضا باری Street address - English: Ahmad-Abad Street, Mashhad Street address - Persian: مشهد، خیابان احمد آباد City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 99199-91766 Phone: +98 51 3840 0000 Fax: Email: dr.alireza.baari@gmail.com Web page address:
#6
Name of recruitment center - English: Sanabad Clinic
Name of recruitment center - Persian: کلینیک سناباد
Full name of responsible person - English: Dr hossein Rahimi
Full name of responsible person - Persian: دکتر حسین رحیمی
Street address - English: Sanabad clinic, Sanabad Street, Mashhad
Street address - Persian: مشهد، خیابان سناباد، کلینیک سناباد
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 0123456789
Phone: +98 51 3843 0606
Fax:
Email: Info@sanabadclinic.com
Web page address:
Name of recruitment center - English: Sanabad Clinic Name of recruitment center - Persian: کلینیک سناباد Full name of responsible person - English: Dr hossein Rahimi Full name of responsible person - Persian: دکتر حسین رحیمی Street address - English: Sanabad clinic, Sanabad Street, Mashhad Street address - Persian: مشهد، خیابان سناباد، کلینیک سناباد City - English: mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 0123456789 Phone: +98 51 3843 0606 Fax: Email: Info@sanabadclinic.com Web page address:
#7
Name of recruitment center - English: Arvand Hospital
Name of recruitment center - Persian: بیمارستان اروند
Full name of responsible person - English: Dr Ali Ehsanpour
Full name of responsible person - Persian: دکتر علی احسانپور
Street address - English: Qanaei Street, Shariati Street, Ahwaz
Street address - Persian: اهواز، خیابان شریعتی، خیابان قنایی
City - English: Ahwaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6155635444
Phone: +98 61 3293 3347
Fax:
Email: drehsanpour@gmail.com
Web page address:
Name of recruitment center - English: Arvand Hospital Name of recruitment center - Persian: بیمارستان اروند Full name of responsible person - English: Dr Ali Ehsanpour Full name of responsible person - Persian: دکتر علی احسانپور Street address - English: Qanaei Street, Shariati Street, Ahwaz Street address - Persian: اهواز، خیابان شریعتی، خیابان قنایی City - English: Ahwaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6155635444 Phone: +98 61 3293 3347 Fax: Email: drehsanpour@gmail.com Web page address:
#8
Name of recruitment center - English: SABA clinic
Name of recruitment center - Persian: کلینیک سبا
Full name of responsible person - English: Dr Mohsen Khani
Full name of responsible person - Persian: دکتر محسن خانی
Street address - English: Morad-Abad alley, Amadgah Street, isfahan
Street address - Persian: اصفهان، خیابان آمادگاه، کوچه مرادآباد
City - English: Isfahan
City - Persian: اصفهان
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1234567890
Phone: +98 31 3222 0455
Fax:
Email: khani.hot@gmail.com
Web page address:
Name of recruitment center - English: SABA clinic Name of recruitment center - Persian: کلینیک سبا Full name of responsible person - English: Dr Mohsen Khani Full name of responsible person - Persian: دکتر محسن خانی Street address - English: Morad-Abad alley, Amadgah Street, isfahan Street address - Persian: اصفهان، خیابان آمادگاه، کوچه مرادآباد City - English: Isfahan City - Persian: اصفهان Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1234567890 Phone: +98 31 3222 0455 Fax: Email: khani.hot@gmail.com Web page address:
#9
Name of recruitment center - English: Naft Hospital
Name of recruitment center - Persian: بیمارستان نفت
Full name of responsible person - English: Dr Behrouz Gharib
Full name of responsible person - Persian: دکتر بهروز غریب
Street address - English: No. 82, Sakhaei street, Hafez street, tehran
Street address - Persian: تهران، خیابان حافظ، خیابان سخایی، پلاک 82
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 0123456789
Phone: +98 21 5417 5000
Fax:
Email: Gharib.behrooz@yahoo.com
Web page address:
Name of recruitment center - English: Naft Hospital Name of recruitment center - Persian: بیمارستان نفت Full name of responsible person - English: Dr Behrouz Gharib Full name of responsible person - Persian: دکتر بهروز غریب Street address - English: No. 82, Sakhaei street, Hafez street, tehran Street address - Persian: تهران، خیابان حافظ، خیابان سخایی، پلاک 82 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 0123456789 Phone: +98 21 5417 5000 Fax: Email: Gharib.behrooz@yahoo.com Web page address:
#10
Name of recruitment center - English: Dr Hashemi Clinic
Name of recruitment center - Persian: مطب دکتر هاشمی
Full name of responsible person - English: Dr Mahdi Hashemi
Full name of responsible person - Persian: دکتر سید مهدی هاشمی
Street address - English: Atieh clinic, Modarres sreet, zahedan
Street address - Persian: زاهدان، خیابان مدرس، مجتمع پزشکان آتیه
City - English: Zahedan
City - Persian: زاهدان
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: 1234567890
Phone: +98 54 3342 6343
Fax:
Email: Hashemimahdi@zuams.ac.ir
Web page address:
Name of recruitment center - English: Dr Hashemi Clinic Name of recruitment center - Persian: مطب دکتر هاشمی Full name of responsible person - English: Dr Mahdi Hashemi Full name of responsible person - Persian: دکتر سید مهدی هاشمی Street address - English: Atieh clinic, Modarres sreet, zahedan Street address - Persian: زاهدان، خیابان مدرس، مجتمع پزشکان آتیه City - English: Zahedan City - Persian: زاهدان Province: Sistan-va-Balouchestan Country: Iran (Islamic Republic of) Postal code: 1234567890 Phone: +98 54 3342 6343 Fax: Email: Hashemimahdi@zuams.ac.ir Web page address:
Protocol summary
Study aim
efficacy and safety of Pertuzumab® (CinnaGen) compared with Perjeta® (Genentech) in neoadjuvant treatment of HER2+ breast cancer patients
Design
after referral to the researchers, in the case of having informed consent will receive a randomization code, and randomly enter in to one of the two groups of pertuzumab and will receive their regimen and they will be evaluated.
Settings and conduct
All drugs are in the same boxes and vials,there is no apparent difference between the Iranian drug and the brand, and the researchers, patients and the data analyzing team will be completely unaware of the type of the drug.
Participants/Inclusion and exclusion criteria
Inclusion: Female aged 18 and older; Operable, locally advanced,inflammatory breast cancer; primary tumor size >2 cm; HER2+; ECOG 0-1, LVEF ≥55%
Exclusion: Metastatic (stage IV) or bilateral breast cancer;Previous systemic or local anticancer therapy;other malignancy except for carcinoma in situ of cervix, basal cell carcinoma, or squamous cell carcinoma of skin; Use of another research drug in the four weeks before study;Major surgery four weeks before study; Uncontrolled hypertension; unstable angina, congestive heart failure, serious cardiac arrhythmia needs treatment,myocardial infarction within 6 months of enrollment, Inadequate bone marrow, liver, or renal function; Shortness of breath during rest or any other disease that requires continuous oxygen therapy, any severe uncontrolled systemic disease; Chronic treatment with corticosteroids; HIV,HBV,HCV infections, Hypersensitivity to studied drugs or excipients; Pregnant, lactating; Unwillingness or inability to fulfill the protocol
Intervention groups
A: Pertuzumab(CinnaGen) with Trastuzumab, Docetaxel and Carboplatin
B: Perjeta(Genentech) with Trastuzumab, Docetaxel and Carboplatin
Main outcome variables
pathologic complete response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N11
Registration date:2018-06-11, 1397/03/21
Registration timing:registered_while_recruiting
Last update:2019-05-28, 1398/03/07
Update count:4
Registration date
2018-06-11, 1397/03/21
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
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Phase III, randomized, two armed, parallel, triple-blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) plus Trastuzumab, Carboplatin and Docetaxel compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company) plus Trastuzumab, Carboplatin and Docetaxel in neoadjuvant treatment of HER 2 positive Breast Cancer patients
Public title
Equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients aged 18 years and older
Operable (T2-3, N0-1, M0), locally advanced (T2-3, N2 or N3, M0; T4a-c, any N, M0), or inflammatory (T4d, any N, M0) breast cancer
Primary tumor diameter should be more than 2 centimeters
Positive HER2 status approved by immunohistochemistry (IHC 3+ or IHC 2+ verified by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH))
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
LVEF ≥55% at baseline assessed by echocardiography
Able and willing to sign an informed consent
Exclusion criteria:
Metastatic (stage IV) or bilateral breast cancer
Previous systemic or local anticancer therapy for any cancer
Any other malignancy except for carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin
Use of another research drug in the four weeks before the start of the study
Major surgery four weeks before the start of the study
Uncontrolled hypertension (systolic blood pressure more than 150 mmHg or/and diastolic blood pressure more than 100 mmHg)
Inadequate bone marrow, liver, or renal function:ANC < 1500/µLPlt < 100,000/µLHb< 9 g/dLALT/AST > 1.5 ULN (upper limit of normal)ALP > 2.5 ULNTotal serum bilirubin > 1.25 ULNSerum creatinine > 1.5 ULN
Shortness of breath during rest or any other disease that requires continuous oxygen therapy
Any severe uncontrolled systemic disease (cardiovascular, pulmonary, metabolic, etc.)
Chronic treatment with corticosteroids with a daily dose of ≥ 10 mg oral prednisolone or equivalent of other types (other than inhaled corticosteroid drugs)
Patients with HIV, HBV, and HCV infections
Hypersensitivity to any of the studied drugs or excipients
Pregnant, lactating or fertile women who do not want to use contraceptive methods (contraceptives should be taken in to consideration up to six months after the last dose of the drug)
Unwillingness or inability to fulfill the requirements of the protocol, including any kind of condition (physical, mental or social) that affects one's ability to fulfill the requirements of the protocol
unstable angina
congestive heart failure of any class of NYHA (New York Heart Association)
serious cardiac arrhythmia needs treatment
history of myocardial infarction within 6 months prior to enrollment
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
214
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be assigned to groups using dynamic randomization, according to these variables:
1- ER/PR: ER/PR+, ER/PR-
2- Type of breast cancer: operable, locally advanced, inflammatory
After randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the first two letters of first name, first two letters of surname) and 4 numbers (center code). Moreover, the described code is followed by study unique identification code consisting of first two letters of the generic name of the investigational product and study phase number, respectively (PE3), and four numbers (corresponding to the randomization number), e.g. ABCD0001PE3-0001. The randomization number will be assigned in a consecutive way, e.g. 0001, 0002, 0003 and so on until the last.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To prevent the influence of knowing intervention group on study conclusion, the subjects and those who assess the study outcomes will be blinded. For this purpose, subjects and administrator of drug will be blinded by using a similar masked vials.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
opposite 17 Shahrivar Hospital, Shahid siadati St. , Namjou St. , Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.GUMS.REC1395.444
2
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth floor, Research Deputy of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulvard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.TUMS.VCR.REC.1397.4973
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
Pathologic Complete Response
Timepoint
before intervention and 3-5 weeks After last intervention
Method of measurement
Pathology laboratory
Secondary outcomes
1
Description
Clinical response rate
Timepoint
before intervention and 3 weeks after last intervention
Method of measurement
Physical examination and imaging (MRI)
2
Description
Rate of breast-conserving surgery
Timepoint
3-5 weeks after last intervention
Method of measurement
Physician report
3
Description
Safety
Timepoint
Every 3 weeks
Method of measurement
Patient’s history and laboratory data
4
Description
Immunogenicity
Timepoint
Every 3 weeks
Method of measurement
Blood test and antidrug antibody presence evaluating
Intervention groups
1
Description
Intervention group: Study drugs are administered intravenously on a 3-weekly schedule for 6 cycles, and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab (cinnagen), carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab is given at an initial dose of 840 mg, followed by 420 mg.
Category
Treatment - Drugs
2
Description
Control group: Control group: Study drugs are administered intravenously on a 3-weekly schedule for 6 cycles, and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab (Perjeta) , carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® in group B is given at an initial dose of 840 mg, followed by 420 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehrad Hospital
Full name of responsible person
Dr. Jahangir Raafat
Street address
Mir Emad St.,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587963110
Phone
+98 21 8874 7401
Email
jahangirraafat@yahoo.com
2
Recruitment center
Name of recruitment center
Jahad daneshgahi center
Full name of responsible person
Dr. Safa Najjar Najafi
Street address
No. 45, West nazari St., Aboureyhan St.,Tehran, iran