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A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
- Cancer
- Breast Cancer
- Breast Cancer HER-2 Positive
- Breast Neoplasms
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Completed
This study runs in
Cities
- 's-Hertogenbosch
- Aarau
- ABD
- Abergavenny
- AEB
- Alacant
- Albacete
- Alexandria Governorate
- Amsterdam
- Ankara
- Antalya
- Antofagasta
- Apeldoorn
- Arequipa
- Arnhem
- Athens
- Augsburg
- Bad Soden am Taunus
- Badalona
- Baden
- Bahia
- Baia Mare
- Banja Luka
- Banskobystrický kraj
- Barcelona
- Bari
- barnstaple
- bedford
- Bellinzona
- Beograd
- Berea
- Bergamo
- Berlin
- Bern
- Besançon
- Bielefeld
- Bilbo
- Birmingham
- Bochum
- bodelwyddan
- Bogotá
- Bordeaux
- Bourg-en-Bresse
- Bournemouth
- Bratislavský kraj
- Brest
- Brive-la-Gaillarde
- București
- Budapest
- Burgos
- Cagliari
- Cairo Governorate
- Cali
- Campeche
- Camperdown
- Camposampiero
- Canterbury
- Caracas
- cascina-perseghetto
- Catania
- Cercado de Lima
- Chalon-sur-Saône
- Chang Wat Chiang Mai
- Chelmsford
- Chihuahua
- Ciudad de Guatemala
- Ciudad de México
- Cluj-Napoca
- Craiova
- Cremona
- Cuenca
- Cáceres
- daerah-istimewa-yogyakarta
- daerah-khusus-ibukota-jakarta
- Debrecen
- Deggendorf
- Derby
- Dijon
- Diyarbakır
- Donostia
- dooradoyle
- Dordrecht
- Draguignan
- Dublin
- Dudley
- Durham
- Ede
- Edmonton
- Eindhoven
- El Palmar
- Elda
- emilia-romagna
- Essen
- Firenze
- Footscray
- Frankston
- Frauenfeld
- Freiburg im Breisgau
- Frosinone
- Gaziantep
- Geleen
- George Town
- Georgsmarienhütte
- Gijón
- Glasgow
- Goyang-si
- greenock
- Grimsby
- Groningen
- Guayaquil
- Guildford
- Guilherand-Granges
- Halle (Saale)
- Hamburg
- Hannover
- Harlow
- Heerlen
- Heidelberg
- Henderson
- Hlavní město Praha
- Hoofddorp
- Huddersfield
- Hyères
- Hà Nội
- Ipswich
- Irkutsk
- Islamabad
- İstanbul
- izhevsk
- jawa-barat
- jawa-timur
- Jaén
- Jeddah
- Jena
- Jihomoravský kraj
- Johannesburg
- Karachi
- Kassel
- Kaunas
- keighley
- Kifisia
- Kilmarnock
- Klaipėda
- Kocaeli
- Kogarah
- Kota Kinabalu
- Košický kraj
- Kragujevac
- Kraków
- Kristiansand
- Krung Thep Maha Nakhon
- Kuala Lumpur
- Kuching
- Kulmbach
- Kyiv
- Köln
- L'Hospitalet de Llobregat
- La Roche-sur-Yon
- La Tronche
- Lahore
- Langen (Hessen)
- Larbert
- Las Palmas de Gran Canaria
- Lausanne
- Lazio
- Le Mans
- Lecce
- Leicester
- Levallois-Perret
- Leverkusen
- León
- Lille
- Lisboa
- livingston
- Lleida
- London
- Longueuil
- Lorient
- Ludwigsburg
- Lviv
- Lyon
- Lübeck
- Macclesfield
- Madrid
- Mainz
- Malvern
- Manchester
- Manila
- Marburg
- Maribor
- Marseille
- Meiningen
- Meldola
- Memmingen
- Mersin
- Metz
- Milano
- Minden
- Moncton
- Montevideo
- Montpellier
- Montréal
- Monza
- Moscow
- Moskva
- Mougins
- México
- Mühlhausen Thüringen
- München
- Münster
- Napoli
- Neuruppin
- New Orleans
- New Territories
- Newcastle upon Tyne
- newport
- Nice
- Nieuwegein
- Niš
- north-shields
- Northampton
- Nyíregyháza
- Nürnberg
- Offenbach am Main
- Olomouc
- orenburg
- Oshawa
- Osijek
- Oslo
- Ostfildern
- Otwock
- Palma
- Pamplona
- Panamá
- Paris
- Parma
- Pau
- Pavia
- Perth
- Piacenza
- Pierre-Bénite
- Pisa
- Plovdiv
- Plymouth
- Pontedera
- Poole
- Porto
- Portsmouth
- Poznań
- Pozuelo de Alarcón
- Preston
- Pretoria
- Prešovský kraj
- Pécs
- Quezon City
- Quito
- Rabat
- Randwick
- Ravenna
- Recklinghausen
- Rio Grande do Sul
- Rionero In Vulture
- Riyadh
- Roma
- Romford
- Roosendaal
- Rotenburg (Wümme)
- Rotterdam
- Rzeszów
- Saarbrücken
- Sabadell
- Saint Petersburg
- Saint-Grégoire
- Saint-Herblain
- Saint-Jean
- Saint-Martin-Boulogne
- Saint-Priest-en-Jarez
- Saint-Quentin
- San Borja
- San Cristóbal de La Laguna
- San Giovanni Rotondo
- Santa Cruz de Tenerife
- Santander
- Santiago
- Santiago de Querétaro
- santiago-de-los-caballeros
- Sarajevo
- Sassari
- Scarborough
- Schiedam
- Schweinfurt
- Schwerin
- Seoul
- Shrewsbury
- Sidi M'Hamed
- Singapore
- Skåne län
- Skövde
- sligo
- slough
- Sofia
- South Carolina
- Southampton
- Sremska Kamenica
- Stavanger
- Stendal
- Strasbourg
- Sunderland
- Surquillo
- Swansea
- Swindon
- Szombathely
- São Paulo
- Taichung City
- Tainan City
- Taipei City
- Tauranga
- Temuco
- Tepic
- Thessaloniki
- Thonon-les-Bains
- Thun
- Timișoara
- tirane
- Toledo
- Torgau
- Torino
- Toronto
- Toruń
- Toulouse
- Trenčiansky kraj
- Truro
- Tübingen
- Ufa
- Unna
- Utrecht
- Valenciennes
- Valparaíso
- València
- Vancouver
- Vandœuvre-lès-Nancy
- Venlo
- Vigo
- Viterbo
- Waterford
- Weinheim
- Weißenfels
- Wetzlar
- winchester
- Windsor
- Winterthur
- Wirral
- Wolverhampton
- Woodville South
- Woolloongabba
- Würselen
- Xàtiva
- York
- Zaandam
- Zagreb
- Zaragoza
- Zárate
- Zürich
- Épagny-Metz-Tessy
- Żory
- София
- أبو ظبي
Trial Identifier:
NCT01566721 2011-005328-17 MO28048
Study Summary
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01566721, MO28048, 2011-005328-17
Trial Identifier
Herceptin
Treatments
Breast Neoplasms
Condition
Official Title
A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
For the latest version of this information please go to www.forpatients.roche.com