225
Participants
Start Date
October 31, 2012
Primary Completion Date
March 31, 2015
Study Completion Date
December 31, 2017
Trastuzumab
Patients will receive 6 courses of trastuzumab in combination with paclitaxel. Trastuzumab will be administered at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations) as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).
Paclitaxel
Paclitaxel will be administered at a dose of 175 mg/m2 every 3 weeks (on Day 1 of each course) as 3 hour intravenous infusion (6 courses totally).
"Institution of Russian Academy of Medical Sciences Russian Cancer Research Center named after N.N. Blokhin", Moscow
"Federal State Institution Moscow Institute of Cancer Research named after P.A. Hertsen Ministry of Health of Russian Federation", Moscow
"State Health Institution of Moscow Moscow City Oncology Hospital #62 of Moscow Board of Health", Stepanovskoye
Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk
Military Medical Academy named after S.M. Kirov, Saint Petersburg
Saint Petersburg City Clinical Oncology Center, Saint Petersburg
N.N.Petrov Oncology Research Center, Saint Petersburg
"Regional State Health Institution Orlov Oncology Dispansary", Oryol
"Federal Government Budgetary Institution Rostov Institute of Cancer Research of Ministry of Health of Russian Federation", Rostov-on-Don
Oncology Dispensary 2, Sochi
"Non-governmental Healthcare Institution Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways", Chelyabinsk
"State-financed Health Institution Stavropol Region Clinical Oncology Dispansary", Stavropol
Volgograd District Oncology Dispensary №1, Volgograd
"State-financed Health Institution Republican Clinical Oncology Hospital", Izhevsk
"State Health Institution Region Oncology Dispansary", Penza
"State-financed Health Institution Samara Region Clinical Oncology Dispansary", Samara
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan, Ufa
"State-financed Health Institution Chelyabinsk Region Clinical Oncology Dispansary", Chelyabinsk
HCG Bangalore Institute of Oncology, Bangalore
M.S.Ramaiah Memorial Hospital, Bangalore
Narayana Hrudayalaya Hospitals, Bangalore
Perm Region Oncology Dispensary, Perm
Brest Region Clinical Oncology Dispensary, Brest
Grodno Regional Hospital, Grodno
Gomel Region Clinical Oncology Dispensary, Homyel
Vitebsk State Medical University of Order of Peoples' Friendship, Vitebsk
Russian scientific center of radiology and surgery technologies, Saint Petersburg
Donetsk City Oncology Dispensary, Donetsk
Donetsk Regional Antitumor Center, Donetsk
Kharkiv Regional Clinical Oncology Center, Kharkiv
Kryvyi Rih Oncology Dispensary, Kryvyi Rih
Lviv Regional State Cancer Diagnostics and Treatment Center, Lviv
City Hospital №2, Makiivka
Poltava Regional Clinical Oncology Dispensary, Poltava
Zakarpatskyi Regional Clinical Oncology Center, Uzhhorod
Vinnytsia Regional Clinical Oncology Dispensary, Vinnytsia
Lead Sponsor
Biocad
INDUSTRY