Spots Global Cancer Trial Database for A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
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Trial Identification
Brief Title: A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
Official Title: A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
Study ID: NCT01419197
Conditions
Study Description
Brief Summary: This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Tucson, Arizona, United States
, Hot Springs, Arkansas, United States
, Hayward, California, United States
, Highland, California, United States
, Oakland, California, United States
, Roseville, California, United States
, Sacramento, California, United States
, San Diego, California, United States
, San Francisco, California, United States
, San Jose, California, United States
, Santa Clara, California, United States
, South San Francisco, California, United States
, Stockton, California, United States
, Vallejo, California, United States
, Walnut Creek, California, United States
, West Hollywood, California, United States
, Denver, Colorado, United States
, Trumbull, Connecticut, United States
, Newark, Delaware, United States
, Washington, District of Columbia, United States
, Coral Springs, Florida, United States
, Deerfield Beach, Florida, United States
, Fort Myers, Florida, United States
, Jacksonville, Florida, United States
, Plantation, Florida, United States
, Marietta, Georgia, United States
, Post Falls, Idaho, United States
, Chicago, Illinois, United States
, Chicago, Illinois, United States
, Maywood, Illinois, United States
, Fort Wayne, Indiana, United States
, Sioux City, Iowa, United States
, Wichita, Kansas, United States
, Scarborough, Maine, United States
, Bethesda, Maryland, United States
, Columbia, Maryland, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Detroit, Michigan, United States
, Minneapolis, Minnesota, United States
, Saint Louis, Missouri, United States
, Omaha, Nebraska, United States
, New Brunswick, New Jersey, United States
, Bronx, New York, United States
, Lake Success, New York, United States
, Charlotte, North Carolina, United States
, Columbus, Ohio, United States
, Portland, Oregon, United States
, Philadelphia, Pennsylvania, United States
, Charleston, South Carolina, United States
, Chattanooga, Tennessee, United States
, Nashville, Tennessee, United States
, Nashville, Tennessee, United States
, Dallas, Texas, United States
, Fort Worth, Texas, United States
, San Antonio, Texas, United States
, Richmond, Virginia, United States
, Seattle, Washington, United States
, Kogarah, New South Wales, Australia
, South Brisbane, Queensland, Australia
, Frankston, Victoria, Australia
, Perth, Western Australia, Australia
, Leuven, , Belgium
, Wilrijk, , Belgium
, Salvador, BA, Brazil
, Goiania, GO, Brazil
, Rio de Janeiro, RJ, Brazil
, Porto Alegre, RS, Brazil
, Itajai, SC, Brazil
, Sao Paulo, SP, Brazil
, Moncton, New Brunswick, Canada
, Toronto, Ontario, Canada
, Regina, Saskatchewan, Canada
, Saskatoon, Saskatchewan, Canada
, Quebec, , Canada
, Brno, , Czech Republic
, Hradec Kralove, , Czech Republic
, Olomouc, , Czech Republic
, Praha 2, , Czech Republic
, Praha 5, , Czech Republic
, Angers, , France
, Bordeaux, , France
, Caen, , France
, Lyon, , France
, Montpellier cedex 5, , France
, Nantes, , France
, Nice, , France
, Nimes, , France
, Paris, , France
, Reims CEDEX, , France
, Rouen, , France
, St-Priest-En-Jarez, , France
, Strasbourg, , France
, Toulouse, , France
, Toulouse, , France
, Tours, , France
, Villejuif, , France
, Bielefeld, , Germany
, Hamburg, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Kiel, , Germany
, Mainz, , Germany
, München, , Germany
, Ravensburg, , Germany
, Recklinghausen, , Germany
, Stuttgart, , Germany
, Trier, , Germany
, Troisdorf, , Germany
, Budapest, , Hungary
, Budapest, , Hungary
, Gyula, , Hungary
, Kecskemet, , Hungary
, Miskolc, , Hungary
, Szeged, , Hungary
, Szolnok, , Hungary
, Bangalore, , India
, Chennai, , India
, Kolkata, , India
, New Delhi, , India
, Pune, , India
, Pune, , India
, Beer Sheva, , Israel
, Hafia, , Israel
, Jerusalem, , Israel
, Petach Tikva, , Israel
, Ramat-Gan, , Israel
, Rehovot, , Israel
, Tel Aviv, , Israel
, Potenza, Basilicata, Italy
, Napoli, Campania, Italy
, Genova, Liguria, Italy
, Bergamo, Lombardia, Italy
, Brescia, Lombardia, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Biella, Piemonte, Italy
, Cona (Ferrara), Veneto, Italy
, Kyunggi-do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Oslo, , Norway
, Bialystok, , Poland
, Bydgoszcz, , Poland
, Gdansk, , Poland
, Lublin, , Poland
, Poznan, , Poland
, Warszawa, , Poland
, Moscow, , Russian Federation
, Samara, , Russian Federation
, Stavropol, , Russian Federation
, Kosice, , Slovakia
, Poprad, , Slovakia
, La Coruna, La Coruña, Spain
, Bilbao, Vizcaya, Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Malaga, , Spain
, Murcia, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Umea, , Sweden
, Uppsala, , Sweden
, Örebro, , Sweden
, Bern, , Switzerland
, Zürich, , Switzerland
, Bangkok, , Thailand
, Bangkok, , Thailand
, Bangkok, , Thailand
, Brighton, , United Kingdom
, Guildford, , United Kingdom
, London, , United Kingdom
, Maidstone, , United Kingdom
, Nottingham, , United Kingdom
, Sheffield, , United Kingdom
, Stoke-on-Trent, , United Kingdom
, Westcliffe-on-sea, , United Kingdom
, Wirral, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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