Spots Global Cancer Trial Database for Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer
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Trial Identification
Brief Title: Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer
Official Title: A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer
Study ID: NCT00820222
Conditions
Study Description
Brief Summary: This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
Detailed Description: The study was terminated based on the IDMC recommendation in 2012, collection of efficacy outcome measures was discontinued and all primary and secondary outcome measures were reported in 2012. An amendment protocol allowed subjects who were on study treatment to enroll in a Long Term Follow Up (LTFU) phase if they had evidence of clinical benefit but no local access to standard of care treatments. Subjects received study treatment until disease progression, unacceptable toxicity, or subject withdrawal. In LTFU only Adverse Events data were collected. For the LTFU the Outcome Measure "Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in \>=2% of participants in either treatment arm" and "Adverse Events" were updated.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Novartis Investigative Site, Goodyear, Arizona, United States
Novartis Investigative Site, Tucson, Arizona, United States
Novartis Investigative Site, Jonesboro, Arkansas, United States
Novartis Investigative Site, Anaheim, California, United States
Novartis Investigative Site, Greenbrae, California, United States
Novartis Investigative Site, Sacramento, California, United States
Novartis Investigative Site, Santa Barbara, California, United States
Novartis Investigative Site, Washington, District of Columbia, United States
Novartis Investigative Site, Boca Raton, Florida, United States
Novartis Investigative Site, Coral Springs, Florida, United States
Novartis Investigative Site, Hollywood, Florida, United States
Novartis Investigative Site, Warrenville, Illinois, United States
Novartis Investigative Site, Metairie, Louisiana, United States
Novartis Investigative Site, Saint Louis, Missouri, United States
Novartis Investigative Site, Great Falls, Montana, United States
Novartis Investigative Site, Voorhees, New Jersey, United States
Novartis Investigative Site, Durham, North Carolina, United States
Novartis Investigative Site, Antwerpen, , Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Sint-Niklaas, , Belgium
Novartis Investigative Site, Aarhus, , Denmark
Novartis Investigative Site, Angers cedex 9, , France
Novartis Investigative Site, Avignon, , France
Novartis Investigative Site, Bayonne cedex, , France
Novartis Investigative Site, Besancon, , France
Novartis Investigative Site, Caen Cedex 05, , France
Novartis Investigative Site, Colmar, , France
Novartis Investigative Site, Dechy, , France
Novartis Investigative Site, Nancy, , France
Novartis Investigative Site, Paris cedex 13, , France
Novartis Investigative Site, Reims Cedex, , France
Novartis Investigative Site, Reims, , France
Novartis Investigative Site, Saint Priest En Jarez Cedex, , France
Novartis Investigative Site, Saint-Gregoire, , France
Novartis Investigative Site, Strasbourg, , France
Novartis Investigative Site, Vannes, , France
Novartis Investigative Site, Ravensburg, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Eggenfelden, Bayern, Germany
Novartis Investigative Site, Fuerth, Bayern, Germany
Novartis Investigative Site, Landshut, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Nuernberg, Bayern, Germany
Novartis Investigative Site, Rosenheim, Bayern, Germany
Novartis Investigative Site, Wuerzburg, Bayern, Germany
Novartis Investigative Site, Potsdam, Brandenburg, Germany
Novartis Investigative Site, Frankfurt, Hessen, Germany
Novartis Investigative Site, Wiesbaden, Hessen, Germany
Novartis Investigative Site, Bottrop, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Duisburg, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Goch, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Herne, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Velbert, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Witten, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Wuerselen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Mainz, Rheinland-Pfalz, Germany
Novartis Investigative Site, Speyer, Rheinland-Pfalz, Germany
Novartis Investigative Site, Halle, Sachsen-Anhalt, Germany
Novartis Investigative Site, Luebeck, Schleswig-Holstein, Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Brandenburg, , Germany
Novartis Investigative Site, Bremen, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, N. Kifisia, Athens, , Greece
Novartis Investigative Site, Neo Faliro, , Greece
Novartis Investigative Site, Patra, , Greece
Novartis Investigative Site, Peiraius, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Kaposvar, , Hungary
Novartis Investigative Site, Tatabanya, , Hungary
Novartis Investigative Site, Veszprem, , Hungary
Novartis Investigative Site, Bologna, Emilia-Romagna, Italy
Novartis Investigative Site, Bologna, Emilia-Romagna, Italy
Novartis Investigative Site, Meldola (FC), Emilia-Romagna, Italy
Novartis Investigative Site, Rimini, Emilia-Romagna, Italy
Novartis Investigative Site, Udine, Friuli-Venezia-Giulia, Italy
Novartis Investigative Site, Roma, Lazio, Italy
Novartis Investigative Site, Monza, Lombardia, Italy
Novartis Investigative Site, Treviglio (BG), Lombardia, Italy
Novartis Investigative Site, Fermo (AP), Marche, Italy
Novartis Investigative Site, Novara, Piemonte, Italy
Novartis Investigative Site, Lido Di Camaiore (LU), Toscana, Italy
Novartis Investigative Site, Pisa, Toscana, Italy
Novartis Investigative Site, Trento, Trentino-Alto Adige, Italy
Novartis Investigative Site, Perugia, Umbria, Italy
Novartis Investigative Site, Varese, , Italy
Novartis Investigative Site, Bydgoszcz, , Poland
Novartis Investigative Site, Bytom, , Poland
Novartis Investigative Site, Gliwice, , Poland
Novartis Investigative Site, Konin, , Poland
Novartis Investigative Site, Lodz, , Poland
Novartis Investigative Site, Olsztyn, , Poland
Novartis Investigative Site, Rzeszow, , Poland
Novartis Investigative Site, Wroclaw, , Poland
Novartis Investigative Site, Wroclaw, , Poland
Novartis Investigative Site, Arkhangelsk, , Russian Federation
Novartis Investigative Site, Chelyabinsk, , Russian Federation
Novartis Investigative Site, Kazan, , Russian Federation
Novartis Investigative Site, Kirov, , Russian Federation
Novartis Investigative Site, Moscow Region, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Nizhniy Novgorod, , Russian Federation
Novartis Investigative Site, Obninsk, , Russian Federation
Novartis Investigative Site, Petrozavodsk, , Russian Federation
Novartis Investigative Site, Ryazan, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Tver, , Russian Federation
Novartis Investigative Site, Velikiy Novgorod, , Russian Federation
Novartis Investigative Site, Voronezh, , Russian Federation
Novartis Investigative Site, Vsevolozhsk, , Russian Federation
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Caceres, , Spain
Novartis Investigative Site, Hospitalet de Llobregat (Barcelona), , Spain
Novartis Investigative Site, Jerez (Cadiz), , Spain
Novartis Investigative Site, La Coruna, , Spain
Novartis Investigative Site, Lerida, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Malaga, , Spain
Novartis Investigative Site, Palma de Mallorca, , Spain
Novartis Investigative Site, Palma de Mallorca, , Spain
Novartis Investigative Site, Santiago de Compostela, , Spain
Novartis Investigative Site, Sevilla, , Spain
Novartis Investigative Site, Sevilla, , Spain
Novartis Investigative Site, Torrevieja (Alicante), , Spain
Novartis Investigative Site, Valencia, , Spain
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Uppsala, , Sweden
Novartis Investigative Site, Vasteras, , Sweden
Novartis Investigative Site, Vaxjo, , Sweden
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Chiangmai, , Thailand
Novartis Investigative Site, Songkla, , Thailand
Novartis Investigative Site, Edinburgh, Midlothian, United Kingdom
Novartis Investigative Site, Birmingham, West Midlands, United Kingdom
Novartis Investigative Site, Aberdeen, , United Kingdom
Novartis Investigative Site, Burton on Trent, , United Kingdom
Novartis Investigative Site, Cottingham, Hull, , United Kingdom
Novartis Investigative Site, Huddersfield, , United Kingdom
Novartis Investigative Site, Ipswich, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Maidstone, , United Kingdom
Novartis Investigative Site, Nottingham, , United Kingdom
Novartis Investigative Site, Peterborough, , United Kingdom
Novartis Investigative Site, Sheffield, , United Kingdom
Novartis Investigative Site, Shrewsbury, , United Kingdom
Novartis Investigative Site, Southampton, , United Kingdom
Novartis Investigative Site, Wolverhampton, , United Kingdom
Novartis Investigative Site, Worthing, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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