Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
NCT ID: NCT00075270
Last Updated: 2015-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
580 participants
INTERVENTIONAL
2004-01-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks
Paclitaxel
Active Comparator
GW572016 (Lapatinib)
Oral GW572016 Lapatinib
Arm 2
Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo
Paclitaxel
Active Comparator
Interventions
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Paclitaxel
Active Comparator
GW572016 (Lapatinib)
Oral GW572016 Lapatinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to swallow an oral medication
* Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
* Adequate kidney and liver function
* Adequate bone marrow function
* Tumor tissue available for testing
* Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
* No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
Exclusion Criteria
* Pregnant or lactating
* Conditions that would effect the absorption of an oral drug
* Active infection
* Brain metastases
* Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
* Known hypersensitivity to Taxol or excipients of Taxol
* Peripheral neuropathy of Grade 2 or greater is not permitted
* Severe Cardiovascular disease or cardiac disease requiring a device.
* Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Rancho Mirage, California, United States
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Vallejo, California, United States
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Denver, Colorado, United States
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Boca Raton, Florida, United States
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Orlando, Florida, United States
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Port Saint Lucie, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Savannah, Georgia, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Springfield, Massachusetts, United States
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Duluth, Minnesota, United States
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Robbinsdale, Minnesota, United States
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St Louis, Missouri, United States
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Voorhees Township, New Jersey, United States
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Santa Fe, New Mexico, United States
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Nyack, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Fargo, North Dakota, United States
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Canton, Ohio, United States
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Portland, Oregon, United States
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Columbia, South Carolina, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Amarillo, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Fitzroy, Victoria, Australia
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Malvern, Victoria, Australia
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Wodonga, Victoria, Australia
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Nedlands, Western Australia, Australia
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Vienna, , Austria
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Bruges, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Salvador, Estado de Bahia, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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St. John's, Newfoundland and Labrador, Canada
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Greater Sudbury, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Santiago, Región Metro de Santiago, Chile
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Santiago, Región Metro de Santiago, Chile
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Santiago, Región Metro de Santiago, Chile
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Aalen, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Bayreuth, Bavaria, Germany
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Coburg, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Fürstenwalde, Brandenburg, Germany
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Hamburg, City state of Hamburg, Germany
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Hamburg, City state of Hamburg, Germany
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Hamburg, City state of Hamburg, Germany
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Stade, Lower Saxony, Germany
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Herne, North Rhine-Westphalia, Germany
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Ibbenbueren, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Halle, Saxony-Anhalt, Germany
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Kiel, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Jena, Thuringia, Germany
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Budapest, , Hungary
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Nyíregyháza, , Hungary
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Szombathely, , Hungary
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Zalaegerszeg-Pózva, , Hungary
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Benevento, Campania, Italy
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Napoli, Campania, Italy
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Forlì, Emilia-Romagna, Italy
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Parma, Emilia-Romagna, Italy
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Ravenna, Emilia-Romagna, Italy
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Rimini, Emilia-Romagna, Italy
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Rome, Lazio, Italy
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Rome, Lazio, Italy
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Pietra Ligure (SV), Liguria, Italy
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Bergamo, Lombardy, Italy
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Pavia, Lombardy, Italy
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Candiolo (TO), Piedmont, Italy
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Turin, Piedmont, Italy
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Sassari, Sardinia, Italy
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Prato (PO), Tuscany, Italy
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Perugia, Umbria, Italy
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Daugavpils, , Latvia
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Liepāja, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Colima, Colima, Mexico
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Durango, Durango, Mexico
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Acapulco de Juárez, Guerrero, Mexico
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Guadalajara, Jalisco, Mexico
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Amersfoort, , Netherlands
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Leiden, , Netherlands
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Nieuwegein, , Netherlands
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Utrecht, , Netherlands
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Utrecht, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Lahore, , Pakistan
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Lahore, , Pakistan
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Lima, Lima Province, Peru
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Callao, , Peru
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Krakow, , Poland
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Olsztyn, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow Region, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Poprad, , Slovakia
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Parktown, Gauteng, South Africa
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Capital Park, , South Africa
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Overport, , South Africa
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Parow, , South Africa
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Port Elizabeth, , South Africa
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Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Alcorcón/Madrid, , Spain
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Baracaldo/Vizcaya, , Spain
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Cáceres, , Spain
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Cuidad Real, , Spain
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Jaén, , Spain
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La Laguna (Santa Cruz de Tenerife), , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Móstoles/Madrid, , Spain
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Palma de Mallorca, , Spain
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Pontevedra, , Spain
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San Sebastián, , Spain
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Santa Cruz de Tenerife, , Spain
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Zaragoza, , Spain
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Zaragoza, , Spain
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Countries
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References
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Tenori L, Oakman C, Claudino WM, Bernini P, Cappadona S, Nepi S, Biganzoli L, Arbushites MC, Luchinat C, Bertini I, Di Leo A. Exploration of serum metabolomic profiles and outcomes in women with metastatic breast cancer: a pilot study. Mol Oncol. 2012 Aug;6(4):437-44. doi: 10.1016/j.molonc.2012.05.003. Epub 2012 Jun 1.
Finn RS, Press MF, Dering J, Arbushites M, Koehler M, Oliva C, Williams LS, Di Leo A. Estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor expression and benefit from lapatinib in a randomized trial of paclitaxel with lapatinib or placebo as first-line treatment in HER2-negative or unknown metastatic breast cancer. J Clin Oncol. 2009 Aug 20;27(24):3908-15. doi: 10.1200/JCO.2008.18.1925. Epub 2009 Jul 20.
Sherrill B, Di Leo A, Amonkar MM, Wu Y, Zvirbule Z, Aziz Z, Bines J, Gomez HL. Quality-of-life and quality-adjusted survival (Q-TWiST) in patients receiving lapatinib in combination with paclitaxel as first-line treatment for metastatic breast cancer. Curr Med Res Opin. 2010 Apr;26(4):767-75. doi: 10.1185/03007991003590860.
Other Identifiers
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EGF30001
Identifier Type: -
Identifier Source: org_study_id
NCT00085046
Identifier Type: -
Identifier Source: nct_alias
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