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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Protocol summary
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
Inclusion: Female aged 18 -70 ; 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
Inclusion: Female aged 18 and older-70 ; 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
ورود: زنان 18 سال و بالاتر؛ سرطان سینه قابل جراحی، locally advanced و یا التهابی با قطر تومور اولیه بیش از 2 CM و +HER2 ؛ ECOG 0-1؛ LVEF حداقل 55%
عدم ورود: سرطان سینه متاستاتیک (Stage IV) یا bilateral؛ بدون سابقه شیمی درمانی یا رادیوتراپی سیستمیک یا لوکال؛هرگونه بدخیمی به جز کارسینوم درجای گردنه رحم و کارسینوم بازال یا فلسی پوست؛سابقه مصرف داروی تحقیقاتی دیگر طی چهار هفته از مطالعه؛سابقه جراحی ماژور طی چهار هفته از مطالعه؛ سابقه پرفشاری خون کنترل نشده، آنژین غیرپایدار، نارسایی قلبی احتقانی، آریتمی قلبی جدی نیازمند به درمان، MI در شش ماه قبل از مطالعه؛ نقص مغز استخوان؛نقص کبدی؛ نقص کلیوی؛تنگی نفس در زمان استراحت یا هر بیماری دیگر که نیازمند اکسیژن درمانی مداوم باشد؛هرگونه بیماری سیستمیک کنترل نشده شدید؛ درمان مزمن با کورتیکواستروئیدها؛عفونت های HCV، HBV و HIV؛ حساسیت به داروهای مطالعه یا اکسپیانت ها؛ بارداری، شیردهی؛ عدم تمایل یا عدم توانایی برای انجام ملزومات پروتکل
ورود: زنان 18 تا 70 سال؛ سرطان سینه قابل جراحی، locally advanced و یا التهابی با قطر تومور اولیه بیش از 2 CM و +HER2 ؛ ECOG 0-1؛ LVEF حداقل 55%
عدم ورود: سرطان سینه متاستاتیک (Stage IV) یا bilateral؛ بدون سابقه شیمی درمانی یا رادیوتراپی سیستمیک یا لوکال؛هرگونه بدخیمی به جز کارسینوم درجای گردنه رحم و کارسینوم بازال یا فلسی پوست؛سابقه مصرف داروی تحقیقاتی دیگر طی چهار هفته از مطالعه؛سابقه جراحی ماژور طی چهار هفته از مطالعه؛ سابقه پرفشاری خون کنترل نشده، آنژین غیرپایدار، نارسایی قلبی احتقانی، آریتمی قلبی جدی نیازمند به درمان، MI در شش ماه قبل از مطالعه؛ نقص مغز استخوان؛نقص کبدی؛ نقص کلیوی؛تنگی نفس در زمان استراحت یا هر بیماری دیگر که نیازمند اکسیژن درمانی مداوم باشد؛هرگونه بیماری سیستمیک کنترل نشده شدید؛ درمان مزمن با کورتیکواستروئیدها؛عفونت های HCV، HBV و HIV؛ حساسیت به داروهای مطالعه یا اکسپیانت ها؛ بارداری، شیردهی؛ عدم تمایل یا عدم توانایی برای انجام ملزومات پروتکل
ورود: زنان 18 تا 70 سال و بالاتر؛ سرطان سینه قابل جراحی، locally advanced و یا التهابی با قطر تومور اولیه بیش از 2 CM و +HER2 ؛ ECOG 0-1؛ LVEF حداقل 55% عدم ورود: سرطان سینه متاستاتیک (Stage IV) یا bilateral؛ بدون سابقه شیمی درمانی یا رادیوتراپی سیستمیک یا لوکال؛هرگونه بدخیمی به جز کارسینوم درجای گردنه رحم و کارسینوم بازال یا فلسی پوست؛سابقه مصرف داروی تحقیقاتی دیگر طی چهار هفته از مطالعه؛سابقه جراحی ماژور طی چهار هفته از مطالعه؛ سابقه پرفشاری خون کنترل نشده، آنژین غیرپایدار، نارسایی قلبی احتقانی، آریتمی قلبی جدی نیازمند به درمان، MI در شش ماه قبل از مطالعه؛ نقص مغز استخوان؛نقص کبدی؛ نقص کلیوی؛تنگی نفس در زمان استراحت یا هر بیماری دیگر که نیازمند اکسیژن درمانی مداوم باشد؛هرگونه بیماری سیستمیک کنترل نشده شدید؛ درمان مزمن با کورتیکواستروئیدها؛عفونت های HCV، HBV و HIV؛ حساسیت به داروهای مطالعه یا اکسپیانت ها؛ بارداری، شیردهی؛ عدم تمایل یا عدم توانایی برای انجام ملزومات پروتکل
General information
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No
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Protocol Amendment
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تغییرات پروتکل
تغییرات پروتکل
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
Female patients aged 18 - 70
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
Female patients aged 18 years and older- 70 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
بیماران زن با سن 18 سال و بالاتر
مبتلا به سرطان سینه قابل جراحی (T2-3, N0-1, M0)، locally advanced (T2-3, N2-3, M0 or T4a-c, any N, M0) یا التهابی (T4d, any N, M0)
قطر تومور اولیه بیش از 2 سانتی متر
وضعیت HER2 مثبت تعیین شده با ایمونوهیستوشیمی (IHC 3+ ، یا IHC 2+ با تایید FISH یا CISH مثبت)
شاخص (ECOG (Eastern Cooperative Oncology Group صفر یا یک
دارای برون ده بطن چپ (LVEF) حداقل 55% اندازه گیری شده با اکوکاردیوگرافی
قادر و مایل به امضای رضایت نامه ی آگاهانه
بیماران زن با سن 18 تا 70 سال
مبتلا به سرطان سینه قابل جراحی (T2-3, N0-1, M0)، locally advanced (T2-3, N2-3, M0 or T4a-c, any N, M0) یا التهابی (T4d, any N, M0)
قطر تومور اولیه بیش از 2 سانتی متر
وضعیت HER2 مثبت تعیین شده با ایمونوهیستوشیمی (IHC 3+ ، یا IHC 2+ با تایید FISH یا CISH مثبت)
شاخص (ECOG (Eastern Cooperative Oncology Group صفر یا یک
دارای برون ده بطن چپ (LVEF) حداقل 55% اندازه گیری شده با اکوکاردیوگرافی
قادر و مایل به امضای رضایت نامه ی آگاهانه
بیماران زن با سن 18 تا 70 سال و بالاتر مبتلا به سرطان سینه قابل جراحی (T2-3, N0-1, M0)، locally advanced (T2-3, N2-3, M0 or T4a-c, any N, M0) یا التهابی (T4d, any N, M0) قطر تومور اولیه بیش از 2 سانتی متر وضعیت HER2 مثبت تعیین شده با ایمونوهیستوشیمی (IHC 3+ ، یا IHC 2+ با تایید FISH یا CISH مثبت) شاخص (ECOG (Eastern Cooperative Oncology Group صفر یا یک دارای برون ده بطن چپ (LVEF) حداقل 55% اندازه گیری شده با اکوکاردیوگرافی قادر و مایل به امضای رضایت نامه ی آگاهانه
Secondary outcomes
#1
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total pathological complete response in breast and axillary lymph nodes
total pathological complete response in breast and axillary lymph nodes
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پاسخ کامل پاتولوژیک در بافت پستان و گره های لنفاوی
پاسخ کامل پاتولوژیک در بافت پستان و گره های لنفاوی
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3-5 weeks After last intervention
3-5 weeks After last intervention
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3 الی 5 هفته بعد از آخرین مداخله
3 الی 5 هفته بعد از آخرین مداخله
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Pathology laboratory
Pathology laboratory
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آزمایش پاتولوژی
آزمایش پاتولوژی
Recruitment centers
#1
Name of recruitment center - English: Shahid Ghazi Hospital
Name of recruitment center - Persian: بیمارستان شهید قاضی
Full name of responsible person - English: Dr Babak Nejati, Dr Ali Esfahani, Dr Alireza Nikanfar, Dr Hadi Chavoshi
Full name of responsible person - Persian: دکتر بابک نجاتی، دکتر علی اصفهانی، دکتر علیرضا نیکانفر، دکتر سید هادی چاوشی
Street address - English: Golgasht St, Daneshgah St, Tabriz
Street address - Persian: تبریز - خیابان دانشگاه - خیابان گل گشت
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 51665-158
Phone: +98 41 3334 3626
Fax:
Email: ali_sfhn@yahoo.com
Web page address:
Name of recruitment center - English: Shams Hospital
Name of recruitment center - Persian: بیمارستان شمس
Full name of responsible person - English: Dr Babak Nejati, Dr Ali Esfahani, Dr Alireza Nikanfar, Dr Hadi Chavoshi
Full name of responsible person - Persian: دکتر بابک نجاتی، دکتر علی اصفهانی، دکتر علیرضا نیکانفر، دکتر سید هادی چاوشی
Street address - English: Shams hospital, Between Abresan and Abbasi intersection, Tabriz
Street address - Persian: تبریز ـ مابین چهارراه آبرسان و چهارراه عباسی بیمارستان شمس تبریز
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 51665-158
Phone: +98 41 3658 3030
Fax:
Email: ali_sfhn@yahoo.com
Web page address:
Name of recruitment center - English: Shahid GhaziShams Hospital Name of recruitment center - Persian: بیمارستان شهید قاضیشمس Full name of responsible person - English: Dr Babak Nejati, Dr Ali Esfahani, Dr Alireza Nikanfar, Dr Hadi Chavoshi Full name of responsible person - Persian: دکتر بابک نجاتی، دکتر علی اصفهانی، دکتر علیرضا نیکانفر، دکتر سید هادی چاوشی Street address - English: Golgasht StShams hospital, Daneshgah StBetween Abresan and Abbasi intersection, Tabriz Street address - Persian: تبریز - خیابان دانشگاه - خیابان گل گشتـ مابین چهارراه آبرسان و چهارراه عباسی بیمارستان شمس تبریز City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 51665-158 Phone: +98 41 3334 36263658 3030 Fax: Email: ali_sfhn@yahoo.com Web page address:
#2
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: Sajjad Hospital
Name of recruitment center - Persian: بیمارستان سجاد
Full name of responsible person - English: Dr. Safa Najjar Najafi
Full name of responsible person - Persian: دکتر صفا نجار نجفی
Street address - English: Chemotherapy Section , Sajjad hospital, Chehelston Street, Dr. Fatemi Square, Tehran
Street address - Persian: میدان دکتر فاطمی نبش خیابان چهلستون، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1431694411
Phone: +98 21 5790 2000
Fax: +98 21 5790 2011
Email: Shahram.Hospital@gmail.com
Web page address:
Name of recruitment center - English: Dr Hashemi ClinicSajjad Hospital Name of recruitment center - Persian: مطب دکتر هاشمیبیمارستان سجاد Full name of responsible person - English: Dr Mahdi Hashemi. Safa Najjar Najafi Full name of responsible person - Persian: دکتر سید مهدی هاشمیصفا نجار نجفی Street address - English: Atieh clinicChemotherapy Section , Modarres sreetSajjad hospital, zahedanChehelston Street, Dr. Fatemi Square, Tehran Street address - Persian: زاهدان،میدان دکتر فاطمی نبش خیابان مدرسچهلستون، مجتمع پزشکان آتیهبخش شیمی درمانی City - English: ZahedanTehran City - Persian: زاهدانتهران Province: Sistan-va-BalouchestanTehran Country: Iran (Islamic Republic of) Postal code: 12345678901431694411 Phone: +98 54 3342 634321 5790 2000 Fax: +98 21 5790 2011 Email: HashemimahdiShahram.Hospital@zuams.ac.irgmail.com Web page address:
#3
Name of recruitment center - English: Tehran Hospital
Name of recruitment center - Persian: بیمارستان تهران
Full name of responsible person - English: Dr. Abdol-Ali Shahrasbi
Full name of responsible person - Persian: دکتر عبدالعلی شهراسبی
Street address - English: Chemotherapy Section , Tehran hospital, 7th Tir Square, Karim Khan Zand St, Sanai St, Tehran
Street address - Persian: تهران ، میدان هفتم تیر ،خیابان کریم خان زند ، خیابان سنایی، بیمارستان تهران ، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۵۸۵۷۳۷۳۱۱
Phone: +98 21 8882 1021
Fax: +98 21 8831 7298
Email: a.sh@gmail.com
Web page address:
Name of recruitment center - English: Tehran Hospital Name of recruitment center - Persian: بیمارستان تهران Full name of responsible person - English: Dr. Abdol-Ali Shahrasbi Full name of responsible person - Persian: دکتر عبدالعلی شهراسبی Street address - English: Chemotherapy Section , Tehran hospital, 7th Tir Square, Karim Khan Zand St, Sanai St, Tehran Street address - Persian: تهران ، میدان هفتم تیر ،خیابان کریم خان زند ، خیابان سنایی، بیمارستان تهران ، بخش شیمی درمانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۵۸۵۷۳۷۳۱۱ Phone: +98 21 8882 1021 Fax: +98 21 8831 7298 Email: a.sh@gmail.com Web page address:
#4
Name of recruitment center - English: IranMehr Hospital
Name of recruitment center - Persian: بیمارستان ایرانمهر
Full name of responsible person - English: Dr. Adnan khosravi
Full name of responsible person - Persian: دکتر عدنان خسروی
Street address - English: Chemotherapy Section, Iranmohr Hospital, Shariati St, Tehran
Street address - Persian: تهران، خیابان شریعتی، نرسیده به دوراهی قلهک، بیمارستان ایرانمهر، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1949913414
Phone: +98 21 2200 9071
Fax: +98 21 2260 2649
Email: info@iranmehrhospital.ir
Web page address:
Name of recruitment center - English: IranMehr Hospital Name of recruitment center - Persian: بیمارستان ایرانمهر Full name of responsible person - English: Dr. Adnan khosravi Full name of responsible person - Persian: دکتر عدنان خسروی Street address - English: Chemotherapy Section, Iranmohr Hospital, Shariati St, Tehran Street address - Persian: تهران، خیابان شریعتی، نرسیده به دوراهی قلهک، بیمارستان ایرانمهر، بخش شیمی درمانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1949913414 Phone: +98 21 2200 9071 Fax: +98 21 2260 2649 Email: info@iranmehrhospital.ir Web page address:
#5
Name of recruitment center - English: Dr Behrooz Najafi Clinic
Name of recruitment center - Persian: مطب دکتر بهروز نجفی
Full name of responsible person - English: Dr. Behrooz Najafi
Full name of responsible person - Persian: دکتر بهروز نجفی
Street address - English: No. 142 , Dr Behrooz Najafi Clinic , Navab Street , next to Golsar Boarding Pharmacy, Rasht, Gilan
Street address - Persian: گیلان، رشت، چهارراه گلسار، جنب داروخانه شبانه روزی گلسار، خیابان نواب، پلاک142 ، مطب دکتر بهروز نجفی
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 1777915311
Phone: +98 13 3211 5049
Fax:
Email: Bnajafi@gums.ac.ir
Web page address:
Name of recruitment center - English: Dr Behrooz Najafi Clinic Name of recruitment center - Persian: مطب دکتر بهروز نجفی Full name of responsible person - English: Dr. Behrooz Najafi Full name of responsible person - Persian: دکتر بهروز نجفی Street address - English: No. 142 , Dr Behrooz Najafi Clinic , Navab Street , next to Golsar Boarding Pharmacy, Rasht, Gilan Street address - Persian: گیلان، رشت، چهارراه گلسار، جنب داروخانه شبانه روزی گلسار، خیابان نواب، پلاک142 ، مطب دکتر بهروز نجفی City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 1777915311 Phone: +98 13 3211 5049 Fax: Email: Bnajafi@gums.ac.ir Web page address:
#6
Name of recruitment center - English: Besat Clinic
Name of recruitment center - Persian: کلینیک تخصصی و فوق تخصصی بعثت
Full name of responsible person - English: Dr. Hossein Mirpour - Dr. Sirus Gharib
Full name of responsible person - Persian: دکتر حسین میرپور - دکتر سیروس غریب
Street address - English: Chemotherapy Section, Besat Clinic, Haji Abad Street, Rasht, Guilan
Street address - Persian: گیلان - رشت - حاجی آباد - کلینیک بعثت
City - English: Guilan
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 1985633753
Phone: +98 13 3326 1448
Fax:
Email: Dr.cygharib@gmail.com
Web page address:
Name of recruitment center - English: Besat Clinic Name of recruitment center - Persian: کلینیک تخصصی و فوق تخصصی بعثت Full name of responsible person - English: Dr. Hossein Mirpour - Dr. Sirus Gharib Full name of responsible person - Persian: دکتر حسین میرپور - دکتر سیروس غریب Street address - English: Chemotherapy Section, Besat Clinic, Haji Abad Street, Rasht, Guilan Street address - Persian: گیلان - رشت - حاجی آباد - کلینیک بعثت City - English: Guilan City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 1985633753 Phone: +98 13 3326 1448 Fax: Email: Dr.cygharib@gmail.com Web page address:
#7
Name of recruitment center - English: Dr Mehdi Mirbolouk Clinic
Name of recruitment center - Persian: مطب دکتر مهدی میربلوک
Full name of responsible person - English: Dr Mehdi Mirbolouk
Full name of responsible person - Persian: دکتر مهدی میربلوک
Street address - English: Dr Mehdi Mirbolouk Clinic, Medical Doctors Building 8, Galsar Intersection of Asgari Street, Rasht, Guilan
Street address - Persian: رشت، چهارراه گلسار نبش کوچه عسگری، ساختمان پزشکان بوسارط8
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4135663341
Phone: +98 13 3211 3588
Fax:
Email: mirboloukmahdi@yahoo.com
Web page address:
Name of recruitment center - English: Dr Mehdi Mirbolouk Clinic Name of recruitment center - Persian: مطب دکتر مهدی میربلوک Full name of responsible person - English: Dr Mehdi Mirbolouk Full name of responsible person - Persian: دکتر مهدی میربلوک Street address - English: Dr Mehdi Mirbolouk Clinic, Medical Doctors Building 8, Galsar Intersection of Asgari Street, Rasht, Guilan Street address - Persian: رشت، چهارراه گلسار نبش کوچه عسگری، ساختمان پزشکان بوسارط8 City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 4135663341 Phone: +98 13 3211 3588 Fax: Email: mirboloukmahdi@yahoo.com Web page address:
#8
Name of recruitment center - English: Baqiyatallah Hospital
Name of recruitment center - Persian: بیمارستان بقیه الله الاعظم (عج)
Full name of responsible person - English: Dr. Mojtaba Ghadiani
Full name of responsible person - Persian: دکتر مجتبی قدیانی
Street address - English: Chemotherapy Section, Baqiyatallah Hospital, Vanak Square, Tehran
Street address - Persian: تهران، میدان ونک، خیابان ملاصدرا بعد از شیخ بهایی بیمارستان بقیه الله الاعظم (عج)، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435915371
Phone: +98 21 81261
Fax:
Email: ghadianymojtaba@yahoo.com
Web page address:
Name of recruitment center - English: Baqiyatallah Hospital Name of recruitment center - Persian: بیمارستان بقیه الله الاعظم (عج) Full name of responsible person - English: Dr. Mojtaba Ghadiani Full name of responsible person - Persian: دکتر مجتبی قدیانی Street address - English: Chemotherapy Section, Baqiyatallah Hospital, Vanak Square, Tehran Street address - Persian: تهران، میدان ونک، خیابان ملاصدرا بعد از شیخ بهایی بیمارستان بقیه الله الاعظم (عج)، بخش شیمی درمانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435915371 Phone: +98 21 81261 Fax: Email: ghadianymojtaba@yahoo.com Web page address:
#9
Name of recruitment center - English: Resalat Hospital
Name of recruitment center - Persian: بیمارستان رسالت
Full name of responsible person - English: Dr. Amir Hossein Emami
Full name of responsible person - Persian: دکتر امیرحسین امامی
Street address - English: Chemotherapy Section, Resalat Hospital, Abouzar Ghaffari Street, Resalat Highway, Tehran
Street address - Persian: تهران - بزرگراه رسالت - ابتدای پل سیدخندان - نبش خیابان ابوذر غفاری - بیمارستان رسالت، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1661613781
Phone: +98 21 2286 9647
Fax:
Email: emamiami@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Resalat Hospital Name of recruitment center - Persian: بیمارستان رسالت Full name of responsible person - English: Dr. Amir Hossein Emami Full name of responsible person - Persian: دکتر امیرحسین امامی Street address - English: Chemotherapy Section, Resalat Hospital, Abouzar Ghaffari Street, Resalat Highway, Tehran Street address - Persian: تهران - بزرگراه رسالت - ابتدای پل سیدخندان - نبش خیابان ابوذر غفاری - بیمارستان رسالت، بخش شیمی درمانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1661613781 Phone: +98 21 2286 9647 Fax: Email: emamiami@sina.tums.ac.ir Web page address:
#10
Name of recruitment center - English: Toos Hospital
Name of recruitment center - Persian: بیمارستان توس
Full name of responsible person - English: Dr. Mohsen Razavi
Full name of responsible person - Persian: دکتر محسن رضوی
Street address - English: Chemotherapy Section, Toos Hospital, Motahhari St., Valiasr Square, Tehran
Street address - Persian: تهران، ميدان حضرت وليعصر، خيابان مطهری، بیمارستان توس، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۵۹۶۹۳۳۱۱۱
Phone: +98 21 8871 4891
Fax:
Email: s_m_raz@yahoo.com
Web page address:
Name of recruitment center - English: Toos Hospital Name of recruitment center - Persian: بیمارستان توس Full name of responsible person - English: Dr. Mohsen Razavi Full name of responsible person - Persian: دکتر محسن رضوی Street address - English: Chemotherapy Section, Toos Hospital, Motahhari St., Valiasr Square, Tehran Street address - Persian: تهران، ميدان حضرت وليعصر، خيابان مطهری، بیمارستان توس، بخش شیمی درمانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۵۹۶۹۳۳۱۱۱ Phone: +98 21 8871 4891 Fax: Email: s_m_raz@yahoo.com Web page address:
#11
Name of recruitment center - English: Dr. Allahyari Clinic
Name of recruitment center - Persian: مطب دکتر ابوالقاسم اللهیاری
Full name of responsible person - English: Dr Abolqasem Allahyari
Full name of responsible person - Persian: دکتر ابوالقاسم اللهیاری
Street address - English: No.6, Next to Asian Insurance, Chamran Ave, Mashhad
Street address - Persian: مشهد، خیابان چمران، نبش چهارراه گلستان، جنب بیمه آسیا، پلاک ۱۷۳
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 0123456789
Phone: +98 51 3858 3050
Fax:
Email: allahyari.abolghasem@yahoo.com
Web page address:
Name of recruitment center - English: Dr. Allahyari Clinic Name of recruitment center - Persian: مطب دکتر ابوالقاسم اللهیاری Full name of responsible person - English: Dr Abolqasem Allahyari Full name of responsible person - Persian: دکتر ابوالقاسم اللهیاری Street address - English: No.6, Next to Asian Insurance, Chamran Ave, Mashhad Street address - Persian: مشهد، خیابان چمران، نبش چهارراه گلستان، جنب بیمه آسیا، پلاک ۱۷۳ City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 0123456789 Phone: +98 51 3858 3050 Fax: Email: allahyari.abolghasem@yahoo.com Web page address:
#12
Name of recruitment center - English: Dr, Bahjat Kalantari Clinic
Name of recruitment center - Persian: مطب دکتر بهجت کلانتری
Full name of responsible person - English: Dr, Bahjat Kalantari
Full name of responsible person - Persian: دکتر بهجت کلانتری
Street address - English: Dr, Bahjat Kalantari Clinic, Park Building, Neshat Park , Kerman
Street address - Persian: کرمان، پارک نشاط ساختمان پارک مطب دکتر بهجت کلانتری
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 32265003
Phone: +98 34 3226 5003
Fax:
Email: dkalantarikhandani@gmail.com
Web page address:
Name of recruitment center - English: Dr, Bahjat Kalantari Clinic Name of recruitment center - Persian: مطب دکتر بهجت کلانتری Full name of responsible person - English: Dr, Bahjat Kalantari Full name of responsible person - Persian: دکتر بهجت کلانتری Street address - English: Dr, Bahjat Kalantari Clinic, Park Building, Neshat Park , Kerman Street address - Persian: کرمان، پارک نشاط ساختمان پارک مطب دکتر بهجت کلانتری City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 32265003 Phone: +98 34 3226 5003 Fax: Email: dkalantarikhandani@gmail.com Web page address:
#13
Name of recruitment center - English: Jawad Al-Ameh Hospital
Name of recruitment center - Persian: مجتمع تخصصی درمانی جوادالائمه(ع)
Full name of responsible person - English: Dr. Vahid Moazed
Full name of responsible person - Persian: دکتر وحید معاضد
Street address - English: Chemistry Section., Jawad al-Ameh Hospital, Alley No. 25, Abu Dharmalm Ave., Kerman
Street address - Persian: کرمان،خیابان ابوذرشمالی،کوچه شماره 25،مجتمع تخصصی درمانی جوادالائمه(ع)، بخش شیمی درمانی
City - English: kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 32510025
Phone: +98 34 3251 0025
Fax:
Email: Moazed_vahid@yahoo.com
Web page address:
Name of recruitment center - English: Jawad Al-Ameh Hospital Name of recruitment center - Persian: مجتمع تخصصی درمانی جوادالائمه(ع) Full name of responsible person - English: Dr. Vahid Moazed Full name of responsible person - Persian: دکتر وحید معاضد Street address - English: Chemistry Section., Jawad al-Ameh Hospital, Alley No. 25, Abu Dharmalm Ave., Kerman Street address - Persian: کرمان،خیابان ابوذرشمالی،کوچه شماره 25،مجتمع تخصصی درمانی جوادالائمه(ع)، بخش شیمی درمانی City - English: kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 32510025 Phone: +98 34 3251 0025 Fax: Email: Moazed_vahid@yahoo.com Web page address:
#14
Name of recruitment center - English: Shahid Baghaei Hospital
Name of recruitment center - Persian: بیمارستان سردار شهید دکتر مجید بقایی
Full name of responsible person - English: Dr. Mehran Hosseinzadeh
Full name of responsible person - Persian: دکتر مهران حسین زاده
Street address - English: Chemotherapy Section, Shahid Baghaei Hospital, Golestan Road, Ahvaz
Street address - Persian: اهواز، انتهای جاده گلستان، بیمارستان سردار شهید دکتر مجید بقایی، بخش شیمی درمانی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 33750000
Phone: +98 61 3375 0000
Fax:
Email: hoseinzadehmehran@gmail.com
Web page address:
Name of recruitment center - English: Shahid Baghaei Hospital Name of recruitment center - Persian: بیمارستان سردار شهید دکتر مجید بقایی Full name of responsible person - English: Dr. Mehran Hosseinzadeh Full name of responsible person - Persian: دکتر مهران حسین زاده Street address - English: Chemotherapy Section, Shahid Baghaei Hospital, Golestan Road, Ahvaz Street address - Persian: اهواز، انتهای جاده گلستان، بیمارستان سردار شهید دکتر مجید بقایی، بخش شیمی درمانی City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 33750000 Phone: +98 61 3375 0000 Fax: Email: hoseinzadehmehran@gmail.com Web page address:
#15
Name of recruitment center - English: Milad Hospital
Name of recruitment center - Persian: بیمارستان میلاد
Full name of responsible person - English: Dr. Fariborz Makarian - Dr. Valiollah Mehrzad
Full name of responsible person - Persian: دکتر فریبرز مکاریان - دکتر ولی الله مهرزاد
Street address - English: Chemotherapy Section, Milad Hospital, Shahid Bakhshi Street, Janbazan Blvd, Isfahan
Street address - Persian: اصفهان، سه راه سیمین، بلوار جانبازان، خیابان شهید بخشی، بیمارستان میلاد، بخش شیمی درمانی
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 37774009
Phone: +98 31 3777 4009
Fax:
Email: valimehrzad@yahoo.com
Web page address:
Name of recruitment center - English: Milad Hospital Name of recruitment center - Persian: بیمارستان میلاد Full name of responsible person - English: Dr. Fariborz Makarian - Dr. Valiollah Mehrzad Full name of responsible person - Persian: دکتر فریبرز مکاریان - دکتر ولی الله مهرزاد Street address - English: Chemotherapy Section, Milad Hospital, Shahid Bakhshi Street, Janbazan Blvd, Isfahan Street address - Persian: اصفهان، سه راه سیمین، بلوار جانبازان، خیابان شهید بخشی، بیمارستان میلاد، بخش شیمی درمانی City - English: Esfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 37774009 Phone: +98 31 3777 4009 Fax: Email: valimehrzad@yahoo.com Web page address:
#16
Name of recruitment center - English: Ebn-Sina Hospital
Name of recruitment center - Persian: بیمارستان ابن سینا
Full name of responsible person - English: Dr Behrouz Gharib
Full name of responsible person - Persian: دکتر بهروز غریب
Street address - English: Chemotherapy Section , Ebn-Sina Hospital, Ayatollah Kashani Boulevard, Tehran
Street address - Persian: تهران، میدام دوم صادقیه، ابتدای بلوار آیت الله کاشانی، بیمارستان ابن سینا، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 47909000
Phone: +98 21 4790 9000
Fax:
Email: gharib.behrooz@yahoo.com
Web page address:
Name of recruitment center - English: Ebn-Sina Hospital Name of recruitment center - Persian: بیمارستان ابن سینا Full name of responsible person - English: Dr Behrouz Gharib Full name of responsible person - Persian: دکتر بهروز غریب Street address - English: Chemotherapy Section , Ebn-Sina Hospital, Ayatollah Kashani Boulevard, Tehran Street address - Persian: تهران، میدام دوم صادقیه، ابتدای بلوار آیت الله کاشانی، بیمارستان ابن سینا، بخش شیمی درمانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 47909000 Phone: +98 21 4790 9000 Fax: Email: gharib.behrooz@yahoo.com Web page address:
#17
Name of recruitment center - English: َAmir Hospital
Name of recruitment center - Persian: بیمارستان امیر
Full name of responsible person - English: Dr. Alireza Rezavani
Full name of responsible person - Persian: دکتر علیرضا رضوانی
Street address - English: Chemotherapy section, Amire shiraz Hospital, Farhang Shahr, Shiraz
Street address - Persian: فرهنگ شهر، بیمارستان امیر شیراز، بخش شیمی درمانی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7187915998
Phone: +98 71 3632 3731
Fax:
Email: Dr.rezvani@hotmail.com
Web page address:
Name of recruitment center - English: َAmir Hospital Name of recruitment center - Persian: بیمارستان امیر Full name of responsible person - English: Dr. Alireza Rezavani Full name of responsible person - Persian: دکتر علیرضا رضوانی Street address - English: Chemotherapy section, Amire shiraz Hospital, Farhang Shahr, Shiraz Street address - Persian: فرهنگ شهر، بیمارستان امیر شیراز، بخش شیمی درمانی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7187915998 Phone: +98 71 3632 3731 Fax: Email: Dr.rezvani@hotmail.com Web page address:
#18
Name of recruitment center - English: Jam Hospital
Name of recruitment center - Persian: بیمارستان جم
Full name of responsible person - English: Dr Arash Jenabian
Full name of responsible person - Persian: دکتر آرش جنابیان
Street address - English: chemotherapy section, jam Hospital, Fajr Street, Shahid Motahri Street, Tehran
Street address - Persian: تهران، خیابان شهید مطهری، خیابان فجرف بیمارستان جم، بخش شیمی درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1588657915
Phone: +98 21 8882 0091
Fax:
Email: arash_jenabian@yahoo.com
Web page address:
Name of recruitment center - English: Jam Hospital Name of recruitment center - Persian: بیمارستان جم Full name of responsible person - English: Dr Arash Jenabian Full name of responsible person - Persian: دکتر آرش جنابیان Street address - English: chemotherapy section, jam Hospital, Fajr Street, Shahid Motahri Street, Tehran Street address - Persian: تهران، خیابان شهید مطهری، خیابان فجرف بیمارستان جم، بخش شیمی درمانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1588657915 Phone: +98 21 8882 0091 Fax: Email: arash_jenabian@yahoo.com 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 -70 ; 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
Protocol Amendment
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N11
Registration date:2018-06-11, 1397/03/21
Registration timing:registered_while_recruiting
Last update:2020-01-14, 1398/10/24
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 - 70
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 to 70 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
5
Description
total pathological complete response in breast and axillary lymph nodes
Timepoint
3-5 weeks After last intervention
Method of measurement
Pathology laboratory
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