488
Participants
Start Date
October 31, 2011
Primary Completion Date
May 31, 2013
Study Completion Date
December 31, 2015
Herceptin
Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 milligrams per kilogram (mg/kg) for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 milligrams (mg) for both the SID and vial formulations for all cycles where SC Herceptin is given.
Herceptin
Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 mg/kg for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 mg for both the SID and vial formulations for all cycles where SC Herceptin is given.
Single-Use Injection Device
The SID will be used, containing Herceptin 600 mg per 5 milliliters (mL).
Single-Use Injection Device
The SID will be used, containing Herceptin 600 mg per 5 mL.
Odense
Baden
Vejle
Herning
Zurich
Berlin
Córdoba
Caen
Fürstenwalde
Genoa
Guadalajara
Milan
Milan
Hamburg
Huesca
Besançon
Pavia
Gaziantep
Madrid
Madrid
Málaga
Hanover
Oviedo
Bordeaux
Rennes
Bornova, ?zm?r
La Tronche
Magedburg
Seville
Seville
Essen
Recklinghausen
Barakaldo
Zamora
Antella (FI)
Mainz
Jönköping
Eskilstuna
Strasbourg
Lyon
LeMans
Paris
Gävle
Sundsvall
Ulm
Saint-Cloud
Bobigny
Deggendorf
Meiningen
Moscow
Saint Petersburg
Kazan'
Orenburg
Yekaterinburg
Irkutsk
Barrie
Brampton
Kitchener
Sault Ste. Marie
Toronto
Saskatoon
Terni
Gdansk
Warsaw
Saint Petersburg
Barcelona
Adana
Ankara
Brighton
Cardiff
Chelmsford
Maidstone
Nottingham
Peterborough
Truro
Hoffmann-La Roche
INDUSTRY