Spots Global Cancer Trial Database for A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Official Title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
Study ID: NCT00829166
Conditions
Study Description
Brief Summary: This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Chandler, Arizona, United States
, Tucson, Arizona, United States
, Anaheim, California, United States
, Anaheim, California, United States
, Bakersfield, California, United States
, Baldwin Park, California, United States
, Bellflower, California, United States
, Duarte, California, United States
, Fontana, California, United States
, Hayward, California, United States
, Irvine, California, United States
, La Jolla, California, United States
, La Mesa, California, United States
, Loma Linda, California, United States
, Long Beach, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, Montebello, California, United States
, Newport Beach, California, United States
, Oakland, California, United States
, Panorama City, California, United States
, Riverside, California, United States
, Roseville, California, United States
, Sacramento, California, United States
, San Diego, California, United States
, San Diego, California, United States
, San Francisco, California, United States
, San Jose, California, United States
, Santa Clara, California, United States
, Santa Maria, California, United States
, Santa Monica, California, United States
, South San Francisco, California, United States
, Thousand Oaks, California, United States
, Vallejo, California, United States
, Walnut Creek, California, United States
, Woodland Hills, California, United States
, Fort Collins, Colorado, United States
, Norwalk, Connecticut, United States
, Norwich, Connecticut, United States
, Stamford, Connecticut, United States
, Washington, District of Columbia, United States
, Boca Raton, Florida, United States
, Fernandina Beach, Florida, United States
, Fort Myers, Florida, United States
, Ft. Lauderdale, Florida, United States
, Hollywood, Florida, United States
, Jacksonville, Florida, United States
, Jacksonville, Florida, United States
, Jacksonville, Florida, United States
, Jacksonville, Florida, United States
, Kissimmee, Florida, United States
, Lakeland, Florida, United States
, Miami, Florida, United States
, Miami, Florida, United States
, Miami, Florida, United States
, Orange Park, Florida, United States
, Pembroke Pines, Florida, United States
, Athens, Georgia, United States
, Atlanta, Georgia, United States
, Atlanta, Georgia, United States
, Atlanta, Georgia, United States
, Atlanta, Georgia, United States
, Carrolton, Georgia, United States
, Cartersville, Georgia, United States
, Decatur, Georgia, United States
, Douglasville, Georgia, United States
, Macon, Georgia, United States
, Marietta, Georgia, United States
, Boise, Idaho, United States
, Meridian, Idaho, United States
, Nampa, Idaho, United States
, Post Falls, Idaho, United States
, Twin Falls, Idaho, United States
, Chicago, Illinois, United States
, Decatur, Illinois, United States
, Effingham, Illinois, United States
, Joliet, Illinois, United States
, Morris, Illinois, United States
, Peoria, Illinois, United States
, Skokie, Illinois, United States
, Zion, Illinois, United States
, Bettendorf, Iowa, United States
, Wichita, Kansas, United States
, Paducah, Kentucky, United States
, Covington, Louisiana, United States
, Lafayette, Louisiana, United States
, Marrero, Louisiana, United States
, Metairie, Louisiana, United States
, New Orleans, Louisiana, United States
, Kittery, Maine, United States
, Wells, Maine, United States
, York, Maine, United States
, Baltimore, Maryland, United States
, Baltimore, Maryland, United States
, Bethesda, Maryland, United States
, Rockville, Maryland, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Burlington, Massachusetts, United States
, Peabody, Massachusetts, United States
, Brownstown, Michigan, United States
, Dearborn, Michigan, United States
, Detroit, Michigan, United States
, Detroit, Michigan, United States
, Saint Joseph, Michigan, United States
, West Bloomfield, Michigan, United States
, Edina, Minnesota, United States
, Maplewood, Minnesota, United States
, Minneapolis, Minnesota, United States
, Saint Louis Park, Minnesota, United States
, Saint Paul, Minnesota, United States
, St. Louis Park, Minnesota, United States
, Joplin, Missouri, United States
, Kansas City, Missouri, United States
, Saint Louis, Missouri, United States
, Saint Peters, Missouri, United States
, St. Louis, Missouri, United States
, St. Peters, Missouri, United States
, Missoula, Montana, United States
, Omaha, Nebraska, United States
, Henderson, Nevada, United States
, Cherry Hill, New Jersey, United States
, Hackensack, New Jersey, United States
, Morristown, New Jersey, United States
, Parsippany, New Jersey, United States
, Voorhees, New Jersey, United States
, Santa Fe, New Mexico, United States
, Brockport, New York, United States
, Canandaigua, New York, United States
, Fresh Meadows, New York, United States
, Geneva, New York, United States
, Greece, New York, United States
, Lake Success, New York, United States
, Mount Kisco, New York, United States
, Rochester, New York, United States
, Stony Brook, New York, United States
, Charlotte, North Carolina, United States
, Durham, North Carolina, United States
, Hickory, North Carolina, United States
, Kinston, North Carolina, United States
, Washington, North Carolina, United States
, Cleveland, Ohio, United States
, Cleveland, Ohio, United States
, Columbus, Ohio, United States
, Columbus, Ohio, United States
, Columbus, Ohio, United States
, Middletown, Ohio, United States
, Newark, Ohio, United States
, Sandusky, Ohio, United States
, Portland, Oregon, United States
, Philadelphia, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, East Providence, Rhode Island, United States
, Columbia, South Carolina, United States
, North Charleston, South Carolina, United States
, Memphis, Tennessee, United States
, Nashville, Tennessee, United States
, Austin, Texas, United States
, Bryan, Texas, United States
, Cypress, Texas, United States
, Dallas, Texas, United States
, El Paso, Texas, United States
, Houston, Texas, United States
, Shenandoah, Texas, United States
, Temple, Texas, United States
, Fairfax, Virginia, United States
, Gig Harbor, Washington, United States
, Lakewood, Washington, United States
, Puyallup, Washington, United States
, Tacoma, Washington, United States
, Milwaukee, Wisconsin, United States
, Wausau, Wisconsin, United States
, Banja Luka, , Bosnia and Herzegovina
, Sarajewo, , Bosnia and Herzegovina
, Belo Horizonte, , Brazil
, Curitiba, , Brazil
, Goiania, , Brazil
, Itajai, , Brazil
, JAU, , Brazil
, Joao Pessoa, , Brazil
, Porto Alegre - Rs, , Brazil
, Porto Alegre, , Brazil
, Porto Alegre, , Brazil
, Porto Alegre, , Brazil
, Rio de Janeiro, , Brazil
, Rio de Janeiro, , Brazil
, Santo Andre, , Brazil
, Sao Paulo, , Brazil
, Sao Paulo, , Brazil
, Plovdiv, , Bulgaria
, Sofia, , Bulgaria
, Sofia, , Bulgaria
, Varna, , Bulgaria
, Calgary, Alberta, Canada
, Edmonton, Alberta, Canada
, Kelowna, British Columbia, Canada
, Vancouver, British Columbia, Canada
, Halifax, Nova Scotia, Canada
, Ottawa, Ontario, Canada
, Sudbury, Ontario, Canada
, Toronto, Ontario, Canada
, Greenfield Park, Quebec, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Bogota, , Colombia
, Bogota, , Colombia
, Monteria, , Colombia
, Herlev, , Denmark
, København, , Denmark
, Odense, , Denmark
, Helsinki, , Finland
, Tampere, , Finland
, Turku, , Finland
, Avignon, , France
, Bordeaux, , France
, Brest, , France
, Caen, , France
, Dijon, , France
, La Roche Sur Yon, , France
, Montpellier, , France
, Paris, , France
, Saint Brieuc, , France
, Saint Herblain, , France
, Vandoeuvre-les-nancy, , France
, Aschaffenburg, , Germany
, Berlin, , Germany
, Berlin, , Germany
, Berlin, , Germany
, Bonn, , Germany
, Dortmund, , Germany
, Freiburg, , Germany
, Fuerstenwalde, , Germany
, Hamburg, , Germany
, Karlsruhe, , Germany
, Kiel, , Germany
, Offenbach, , Germany
, Stralsund, , Germany
, Hong Kong, , Hong Kong
, Bangalore, , India
, Gurgaon, , India
, Kolkata, , India
, New Delhi, , India
, Pune, , India
, Aviano, , Italy
, Bologna, , Italy
, Candiolo, , Italy
, Genova, , Italy
, Meldola, , Italy
, Milano, , Italy
, Milano, , Italy
, Napoli, , Italy
, Negrar, , Italy
, Pisa, , Italy
, Reggio Emilia, , Italy
, Roma, , Italy
, Rozzano, , Italy
, Sassari, , Italy
, Terni, , Italy
, Kyunggi-do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Acapulco, , Mexico
, Oaxaca, , Mexico
, Toluca, , Mexico
, Newtown, , New Zealand
, Palmerston North, , New Zealand
, Diliman, Quezon City, , Philippines
, Quezon City, Luzon, , Philippines
, Bialystok, , Poland
, Gdansk, , Poland
, Krakow, , Poland
, Lublin, , Poland
, Opole, , Poland
, Poznan, , Poland
, Warszawa, , Poland
, Coimbra, , Portugal
, Lisboa, , Portugal
, Porto, , Portugal
, Kemerovo, , Russian Federation
, Moscow, , Russian Federation
, St Petersburg, , Russian Federation
, Singapore, , Singapore
, Singapore, , Singapore
, Ljubljana, , Slovenia
, Barcelona, , Spain
, Córdoba, , Spain
, Lerida, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Santander, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Zaragoza, , Spain
, Eskilstuna, , Sweden
, Gaelve, , Sweden
, Goteborg, , Sweden
, Luzern, , Switzerland
, St. Gallen, , Switzerland
, Kaohsung, , Taiwan
, Taichung, , Taiwan
, Taichung, , Taiwan
, Taipei, , Taiwan
, Taoyuan, , Taiwan
, Bournemouth, , United Kingdom
, Cardiff, , United Kingdom
, Denbigh, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, New Castle Upon Tyne, , United Kingdom
, Northwood, , United Kingdom
, Poole, , United Kingdom
, Preston, , United Kingdom
, Romford, , United Kingdom
, Sutton, , United Kingdom
, Weston Super Mare, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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