Spots Global Cancer Trial Database for Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
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Trial Identification
Brief Title: Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
Official Title: A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)
Study ID: NCT01401166
Conditions
Study Description
Brief Summary: This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
, Barrie, Ontario, Canada
, Brampton, Ontario, Canada
, Kitchener, Ontario, Canada
, Sault Ste Marie, Ontario, Canada
, Toronto, Ontario, Canada
, Saskatoon, Saskatchewan, Canada
, Herning, , Denmark
, Odense, , Denmark
, Vejle, , Denmark
, Besancon, , France
, Bobigny, , France
, Bordeaux, , France
, Caen, , France
, La Tronche, , France
, LeMans, , France
, Lyon, , France
, Paris, , France
, Rennes, , France
, St Cloud, , France
, Strasbourg, , France
, Berlin, , Germany
, Deggendorf, , Germany
, Essen, , Germany
, Fuerstenwalde, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Magedburg, , Germany
, Mainz, , Germany
, Meiningen, , Germany
, Recklinghausen, , Germany
, Ulm, , Germany
, Genova, Liguria, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Pavia, Lombardia, Italy
, Antella (FI), Toscana, Italy
, Terni, Umbria, Italy
, Gdansk, , Poland
, Warszawa, , Poland
, Ekaterinburg, , Russian Federation
, Irkutsk, , Russian Federation
, Kazan, , Russian Federation
, Moscow, , Russian Federation
, Orenburg, , Russian Federation
, Saint-Petersburg, , Russian Federation
, St Petersburg, , Russian Federation
, Oviedo, Asturias, Spain
, Barakaldo, Vizcaya, Spain
, Barcelona, , Spain
, Cordoba, , Spain
, Guadalajara, , Spain
, Huesca, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Malaga, , Spain
, Sevilla, , Spain
, Sevilla, , Spain
, Zamora, , Spain
, Eskilstuna, , Sweden
, Gävle, , Sweden
, Jonkoping, , Sweden
, Sundsvall, , Sweden
, Baden, , Switzerland
, Zürich, , Switzerland
, Adana, , Turkey
, Ankara, , Turkey
, Bornova, ?ZM?R, , Turkey
, Gaziantep, , Turkey
, Brighton, , United Kingdom
, Cardiff, , United Kingdom
, Chelmsford, , United Kingdom
, Maidstone, , United Kingdom
, Nottingham, , United Kingdom
, Peterborough, , United Kingdom
, Truro, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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