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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
- Breast Cancer HER-2 Positive
Trial Status:
Completed
This trial 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
Trial 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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%
Exclusion Criteria
- Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
- History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
- Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
- Metastatic disease
- Inadequate bone marrow, hepatic, or renal function
- Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- History of severe allergic or immunological reactions, such as difficult-to-control asthma
- Pregnant or lactating women
For the latest version of this information please go to www.forpatients.roche.com