The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Condition	Treatment or Intervention	Phase
Metastatic breast cancer	Drug: Paclitaxel  Drug: GW572016	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion criteria:

• Signed Informed Consent
• 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 mitoxantrome
• No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested

Exclusion criteria:

• Prior treatment regimens for advanced or metastatic breast cancer.
• 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 excipents of Taxol
• Peripheral neuropathy of Grade 2 or greater is not permited
• 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.

Arizona
      Tucson,  Arizona,  85715,  United States; Recruiting
Arkansas
      Hot Springs,  Arkansas,  71913,  United States; Recruiting
      Jonesboro,  Arkansas,  72401,  United States; Recruiting
California
      La Jolla,  California,  92037,  United States; Recruiting
      Rancho Mirage,  California,  92270,  United States; Recruiting
      Fountain Valley,  California,  92708,  United States; Recruiting
      Fountain Valley,  California,  92708,  United States; Not yet recruiting
      Vallejo,  California,  94589,  United States; Recruiting
Colorado
      Denver,  Colorado,  80011,  United States; Recruiting
Connecticut
      Hartford,  Connecticut,  06105,  United States; Terminated
      New Haven,  Connecticut,  06520,  United States; Terminated
      Norwalk,  Connecticut,  06856,  United States; Terminated
District of Columbia
      Washington,  District of Columbia,  20007,  United States; Not yet recruiting
Florida
      Orlando,  Florida,  32804,  United States; Recruiting
      West Palm Beach,  Florida,  33401,  United States; Terminated
      Boca Raton,  Florida,  33428,  United States; Terminated
      Boca Raton,  Florida,  33486,  United States; Recruiting
      Fort Myers,  Florida,  33901,  United States; Terminated
      Port St. Lucie,  Florida,  34952,  United States; Recruiting
Georgia
      Marietta,  Georgia,  30060,  United States; Recruiting
      Roswell,  Georgia,  30076,  United States; Not yet recruiting
      Tucker,  Georgia,  30084,  United States; Recruiting
      Atlanta,  Georgia,  30322,  United States; Terminated
      Atlanta,  Georgia,  30607,  United States; Not yet recruiting
      Savannah,  Georgia,  31405,  United States; Not yet recruiting
      Savannah,  Georgia,  31406,  United States; Recruiting
Indiana
      Indianapolis,  Indiana,  46260,  United States; Recruiting
      Terre Haute,  Indiana,  47802,  United States; Terminated
Kansas
      Kansas City,  Kansas,  66160-7145,  United States; Recruiting
Louisiana
      Metairie,  Louisiana,  70006,  United States; Recruiting
      New Orleans,  Louisiana,  70121,  United States; Terminated
      Shreveport,  Louisiana,  71103,  United States; Terminated
Maryland
      Baltimore,  Maryland,  21201,  United States; Not yet recruiting
Massachusetts
      Springfield,  Massachusetts,  01107,  United States; Recruiting
Minnesota
      Robbinsdale,  Minnesota,  55422,  United States; Recruiting
Missouri
      St. Louis,  Missouri,  63110,  United States; Terminated
      St. Louis,  Missouri,  63141,  United States; Recruiting
      St. Louis,  Missouri,  63141,  United States; Recruiting
New Jersey
      Voorhees,  New Jersey,  08043,  United States; Recruiting
New Mexico
      Albuquerque,  New Mexico,  87131-0001,  United States; Not yet recruiting
      Santa Fe,  New Mexico,  87505,  United States; Recruiting
New York
      Nyack,  New York,  10960,  United States; Recruiting
      Syracuse,  New York,  13210,  United States; Recruiting
North Carolina
      Greenville,  North Carolina,  27834,  United States; Terminated
      Charlotte,  North Carolina,  28203,  United States; Not yet recruiting
North Dakota
      Fargo,  North Dakota,  58103,  United States; Recruiting
Ohio
      Canton,  Ohio,  44713,  United States; Recruiting
Oregon
      Portland,  Oregon,  97227-1191,  United States; Recruiting
South Carolina
      Columbia,  South Carolina,  29210,  United States; Recruiting
Tennessee
      Memphis,  Tennessee,  36104,  United States; Terminated
      Knoxville,  Tennessee,  37916,  United States; Recruiting
      Knoxville,  Tennessee,  37920,  United States; Not yet recruiting
Texas
      Arlington,  Texas,  76012,  United States; Not yet recruiting
      Fort Worth,  Texas,  76104,  United States; Recruiting
      Houston,  Texas,  77025,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; Recruiting
      Amarillo,  Texas,  79106,  United States; Recruiting
Vermont
      Burlington,  Vermont,  05401,  United States; Recruiting
Virginia
      Norfolk,  Virginia,  23501,  United States; Not yet recruiting
Washington
      Tacoma,  Washington,  98405,  United States; Recruiting
Wisconsin
      Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Belgium
      Brussels,  1070,  Belgium; Not yet recruiting
      Brussels,  1090,  Belgium; Not yet recruiting
      Leuven,  3000,  Belgium; Not yet recruiting
      Roeselare,  8800,  Belgium; Recruiting
Canada, Newfoundland and Labrador
      Saint John's,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Canada, Ontario
      Sudbury,  Ontario,  P3E 5J1,  Canada; Recruiting
Canada, Quebec
      Montreal,  Quebec,  H3T 1E2,  Canada; Recruiting
      Montreal,  Quebec,  H4J 1C5,  Canada; Recruiting
      Fleurimont,  Quebec,  J1H 5N4,  Canada; Recruiting
Czech Republic
      Praha 10,  10034,  Czech Republic; Not yet recruiting
      HRADEC KRALOVE,  500 05,  Czech Republic; Recruiting
      Brno,  656 63,  Czech Republic; Recruiting
      Olomouc,  775 20,  Czech Republic; Not yet recruiting
Germany
      Berlin,  10177,  Germany; Recruiting
      Berlin,  13053,  Germany; Recruiting
      Berlin,  13353,  Germany; Recruiting
      Berlin,  14195,  Germany; Recruiting
      Hamburg,  20259,  Germany; Recruiting
      Hamburg,  22457,  Germany; Recruiting
      Hamburg,  22765,  Germany; Recruiting
Germany, Baden-Wurttemberg
      Ibbenbuergen,  Baden-Wurttemberg,  49477,  Germany; Recruiting
      Stuttgart,  Baden-Wurttemberg,  70176,  Germany; Recruiting
      Aalen,  Baden-Wurttemberg,  73428,  Germany; Recruiting
      Ulm,  Baden-Wurttemberg,  89075,  Germany; Recruiting
Germany, Bayern
      Munchen,  Bayern,  80637,  Germany; Recruiting
      Munchen,  Bayern,  81377,  Germany; Recruiting
      Augsburg,  Bayern,  86150,  Germany; Recruiting
      Bayreuth,  Bayern,  95445,  Germany; Recruiting
      Coburg,  Bayern,  96450,  Germany; Recruiting
Germany, Brandenburg
      Furstenwalde,  Brandenburg,  15517,  Germany; Recruiting
Germany, Niedersachsen
      Stade,  Niedersachsen,  21680,  Germany; Recruiting
      Hannover,  Niedersachsen,  30659,  Germany; Recruiting
Germany, Nordrhein-Westfalen
      Herne,  Nordrhein-Westfalen,  44625,  Germany; Recruiting
      Munster,  Nordrhein-Westfalen,  48149,  Germany; Recruiting
Germany, Sachsen
      Schkeuditz,  Sachsen,  04435,  Germany; Recruiting
Germany, Sachsen-Anhalt
      Italle,  Sachsen-Anhalt,  6120,  Germany; Recruiting
Germany, Thuringen
      Erfurt,  Thuringen,  99089,  Germany; Recruiting
Hungary
      Budapest,  1082,  Hungary; Recruiting
      Nylregyhaza,  4400,  Hungary; Recruiting
      Pecs,  7623,  Hungary; Recruiting
      Zalaegerszeg-Pozva,  8900,  Hungary; Recruiting
      Szombathely,  9700,  Hungary; Not yet recruiting
Latvia
      Riga,  LV 1050,  Latvia; Not yet recruiting
      Riga,  LV 1079,  Latvia; Not yet recruiting
      Liepaja,  LV 3401,  Latvia; Not yet recruiting
      Daugavpils,  LV 5420,  Latvia; Not yet recruiting
Poland
      Warszawa,  02-781,  Poland; Recruiting
      Olsztyn,  10-228,  Poland; Recruiting
      Krakow,  31-826,  Poland; Recruiting
      Poznan,  61-866,  Poland; Recruiting
Russian Federation
      Moscow,  105005,  Russian Federation; Recruiting
      Moscow,  115478,  Russian Federation; Recruiting
      Moscow,  117837,  Russian Federation; Recruiting
      Moscow,  129128,  Russian Federation; Recruiting
      Moscow,  129301,  Russian Federation; Recruiting
      Moscow,  143423,  Russian Federation; Recruiting
      St Petersburg,  197022,  Russian Federation; Recruiting
      St Petersburg,  197758,  Russian Federation; Recruiting
      St Petersburg,  197758,  Russian Federation; Recruiting
Slovakia
      Kosice,  04190,  Slovakia; Not yet recruiting
      Poprad,  05801,  Slovakia; Not yet recruiting
      Bratislava,  83103,  Slovakia; Not yet recruiting
      Banska Bystrica,  97517,  Slovakia; Not yet recruiting
Spain
      Caceres,  10003,  Spain; Not yet recruiting
      Ciudad Real,  13002,  Spain; Not yet recruiting
      Cordoba,  14004,  Spain; Not yet recruiting
      San Sebastian,  20014,  Spain; Not yet recruiting
      Jaen,  23007,  Spain; Recruiting
      Madrid,  28035,  Spain; Recruiting
      Madrid,  28922,  Spain; Not yet recruiting
      Las Palmas de Gran Cana,  35016,  Spain; Not yet recruiting
      Pontevedra,  36001,  Spain; Recruiting
      Tenerife,  38320,  Spain; Recruiting
      Bilbao,  48903,  Spain; Recruiting
      Zaragoza,  50009,  Spain; Not yet recruiting
      Zaragoza,  50009,  Spain; Not yet recruiting
      Palma de Mallorca,  7014,  Spain; Recruiting
Spain, Madrid
      Mostoles,  Madrid,  28935,  Spain; Recruiting

Study ID Numbers:  EGF30001
Record last reviewed:  October 2004
Record first received:  January 7, 2004
ClinicalTrials.gov Identifier:  NCT00075270
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10