500
Participants
Start Date
July 31, 2012
Primary Completion Date
March 31, 2016
Study Completion Date
August 31, 2018
Trastuzumab
Trastuzumab 8mg/kg Iv over 90 minutes x 1 then Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks
MYL- 1401O
MYL-1401O 8mg/kg Iv over 90 minutes x 1 then HERMyl 1401O Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks
Paclitaxel
Paclitaxel 80mg/m2 IV over 60 minutes weekly.
Docetaxel
Docetaxel 75mg/m2 IV over 60 minutes on day 1 of a 3 week cycle
Mylan Investigational Site, Barretos
Mylan Investigational Site, Brasília
Mylan Investigational Site, Goiânia
Mylan Investigational Site, Ijuí
Mylan Investigational Site, Jaú
Mylan Investigational Site, Joinville
Mylan Investigational Site, Morumbi
Mylan Investigational Site, Porto Alegre
Mylan Investigational Site, Salvador
Mylan Investigational Site, Santo André
Mylan Investigational Site, São Paulo
Mylan Investigational Site, Sorocaba
Mylan Investigational Site, Santiago
Mylan Investigational Site, Temuco
Mylan Investigational Site, Batumi
Mylan Investigational Site, Tbilisi
Mylan Investigational Site, Budapest
Mylan Investigational Site, Debrecen
Mylan Investigational Site, Gyód
Mylan Investigational Site, Gyula
Mylan Investigational Site, Miskolc
Mylan Investigational Site, Nyíregyháza
Mylan Investigational Site, Szekszárd
Mylan Investigational Site, Szolnok
Mylan Investigational Site, Ahmedabad
Mylan Investigational Site, Bangalore
Mylan Investigational Site, Chennai
Mylan Investigational Site, Gūrgaon
Mylan Investigational Site, Hyderabad
Mylan Investigational Site, Jaipur
Mylan Investigational Site, Karamsad
Mylan Investigational Site, Madurai
Mylan Investigational Site, Mumbai
Mylan Investigational Site, Nashik
Mylan Investigational Site, Pune
Mylan Investigational Site, Surat
Mylan Investigational Site, Vijaywada
Mylan Investigational Site, Daugavpils
Mylan Investigational Site, Leipaja
Mylan Investigational Site, Riga
Mylan Investigational Site, Arequipa
Mylan Investigational Site, Lima
Mylan Investigational Site, Surquillo
Mylan Investigational Site, Brasov
Mylan Investigational Site, Bucharest
Mylan Investigational Site, Cluj-Napoca
Mylan Investigational Site, Constanța
Mylan Investigational Site, Craiva
Mylan Investigational Site, Făurei
Mylan Investigational Site, Iași
Mylan Investigational Site, Oradea
Mylan Investigational Site, Timișoara
Mylan Investigational Site, Arkhangelsk
Mylan Investigational Site, Ivanovo
Mylan Investigational Site, Kazan'
Mylan Investigational Site, Kursk
Mylan Investigational Site, Moscow
Mylan Investigational Site, Rostov-on-Don
Mylan Investigational Site, Ryazan
Mylan Investigational Site, Saint Petersburg
Mylan Investigational Site, Samara
Mylan Investigational Site, Belgrade
Mylan Investigational Site, Kamenica
Mylan Investigational Site, Sremska
Mylan Investigational Site, Bardejov
Mylan Investigational Site, Košice
Mylan Investigational Site, Nové Zámky
Mylan Investigational Site, Trnava
Mylan Investigator Site, Bloemfontein
Mylan Investigator Site, Durban
Mylan Investigational Site, George
Mylan Investigational Site, Johannesburg
Mylan Investigator Site, Kraaifontein
Mylan Investigational Site, Port Elizabeth
Mylan Investigational Site, Pretoria
Mylan Investigational Site, Vereeniging
Mylan Investigator Site, Bangkok
Mylan Investigator Site, Chiang Mai
Mylan Investigator Site, Phitsanulok
Mylan Investigator Site, Rajthavee
Mylan Investigator Site, Songkhla
Mylan Investigator Site, Ankara
Mylan Investigator Site, Istanbul
Mylan Investigator Site, Izmir
Mylan Investigator Site, Kocaeli
Mylan Investigator Site, Cherkassy
Mylan Investigator Site, Chernivtsi
Mylan Investigator Site, Dnipropetrovsk
Mylan Investigator Site, Lutsk
Mylan Investigator Site, Lviv
Mylan Investigator Site, Sumy
Mylan Investigator Site, Uzhhorod
Lead Sponsor
Mylan GmbH
INDUSTRY
Mylan Inc.
INDUSTRY