This study will compare the efficacy and tolerability of GW572016 administered in combination with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive advanced or metastatic breast cancer.

Condition	Treatment or Intervention	Phase
Breast Cancer Metastases	Drug: Lapatinib (GW572016)  Drug: Letrozole	Phase III

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

Criteria

Inclusion Criteria:

• Signed informed consent
• Stage IIIb, Stage IIIc with T4 lesion, or Stage IV breast cancer
• Tumors that are estrogen and/or progesterone receptor-positive
• Post-menopausal women
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Tumor tissue available for testing
• Able to swallow and retain oral medication
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or multigated acquisition (MUGA) scan
• Adequate kidney, liver, and bone marrow function

Exclusion Criteria:

• Pre-menopausal, pregnant, or lactating females
• Received prior thereapy for advanced or metastatic breast cancer
• Received anthracyclines in the neo-adjuvant and/or adjuvant setting, which exceeded the following doses: 360 mg/m2 of Doxorubicin, 720 mg/m2 of Epirubicin, and 72 mg/m2 of Mitoxantrone
• Conditions that would affect absorption of an oral drug
• Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent
• Active infection
• Uncontrolled or symptomatic cardiac conditions (e.g., angina, arrhythmias, or congestive heart failure)
• Brain metastases
• Concurrent cancer therapy or investigational therapy
• Unresolved or unstable serious toxicity from prior therapy

Arizona
      Tucson,  Arizona,  85712,  United States; Recruiting
      Tucson,  Arizona,  85724,  United States; Not yet recruiting
Arkansas
      Hot Springs,  Arkansas,  71913,  United States; Recruiting
      Jonesboro,  Arkansas,  72401,  United States; Recruiting
California
      Los Angeles,  California,  90057,  United States; Recruiting
      Los Angeles,  California,  90095,  United States; Not yet recruiting
      Redondo Beach,  California,  90277,  United States; Recruiting
      Long Beach,  California,  90813,  United States; Recruiting
      Northridge,  California,  91328,  United States; Recruiting
      Monterey Park,  California,  91754,  United States; Recruiting
      Pomona,  California,  91767,  United States; Recruiting
      La Jolla,  California,  92037,  United States; Not yet recruiting
      Vista,  California,  92083,  United States; Not yet recruiting
      Fountain Valley,  California,  92708,  United States; Recruiting
      Fullerton,  California,  92835,  United States; Recruiting
      Oxnard,  California,  93030,  United States; Not yet recruiting
      Santa Barbara,  California,  93105,  United States; Recruiting
      Santa Barbara,  California,  93105,  United States; Recruiting
      Porterville,  California,  93257,  United States; Recruiting
      Bakersfield,  California,  93309,  United States; Recruiting
      Fresno,  California,  93710,  United States; Recruiting
      San Francisco,  California,  94115,  United States; Not yet recruiting
      Concord,  California,  94520,  United States; Recruiting
      Vallejo,  California,  94789,  United States; Recruiting
Colorado
      Aurora,  Colorado,  80010,  United States; Recruiting
      Wheat Ridge,  Colorado,  80033,  United States; Recruiting
      Denver,  Colorado,  80218,  United States; Recruiting
      Longmont,  Colorado,  80501,  United States; Recruiting
Connecticut
      Hartford,  Connecticut,  06105,  United States; Recruiting
      New Haven,  Connecticut,  06520,  United States; Not yet recruiting
Florida
      Gainesville,  Florida,  32605,  United States; Recruiting
      Gainesville,  Florida,  32610,  United States; Recruiting
      Orlando,  Florida,  32804,  United States; Recruiting
      Plantation,  Florida,  33324,  United States; Recruiting
      West Palm Beach,  Florida,  33401,  United States; Recruiting
      Boca Raton,  Florida,  33428,  United States; Recruiting
      Boca Raton,  Florida,  33428,  United States; Recruiting
      Lakeland,  Florida,  33805,  United States; Recruiting
      Lakeland,  Florida,  33805,  United States; Recruiting
      Port St. Lucie,  Florida,  34952,  United States; Recruiting
Georgia
      Marietta,  Georgia,  30060,  United States; Recruiting
      Tucker,  Georgia,  30084,  United States; Recruiting
      Savannah,  Georgia,  31406,  United States; Recruiting
Illinois
      Skokie,  Illinois,  60076,  United States; Recruiting
      Peoria,  Illinois,  61602,  United States; Recruiting
Iowa
      Bettendorf,  Iowa,  52722,  United States; Recruiting
Kentucky
      Louisville,  Kentucky,  40202,  United States; Not yet recruiting
Louisiana
      Metairie,  Louisiana,  70006,  United States; Recruiting
      New Orleans,  Louisiana,  70121,  United States; Not yet recruiting
Maryland
      Annapolis,  Maryland,  21401,  United States; Recruiting
Massachusetts
      Worcester,  Massachusetts,  01608,  United States; Recruiting
Michigan
      Royal Oak,  Michigan,  48073,  United States; Not yet recruiting
Minnesota
      Minneapolis,  Minnesota,  55407,  United States; Not yet recruiting
      St. Louis Park,  Minnesota,  55416,  United States; Not yet recruiting
      Robbinsdale,  Minnesota,  55422,  United States; Recruiting
      Duluth,  Minnesota,  55805,  United States; Recruiting
Missouri
      St. Louis,  Missouri,  63141,  United States; Recruiting
      St. Charles,  Missouri,  63301,  United States; Recruiting
Montana
      Great Falls,  Montana,  56405,  United States; Recruiting
Nebraska
      Omaha,  Nebraska,  68114,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  89109,  United States; Recruiting
New Jersey
      Voorhees,  New Jersey,  08043,  United States; Recruiting
New Mexico
      Albuquerque,  New Mexico,  87102,  United States; Not yet recruiting
      Santa Fe,  New Mexico,  87505,  United States; Recruiting
New York
      New York,  New York,  10021,  United States; Not yet recruiting
      Manhasset,  New York,  11030,  United States; Recruiting
      Syracuse,  New York,  13210,  United States; Not yet recruiting
      Rochester,  New York,  14623,  United States; Recruiting
North Carolina
      Chapel Hill,  North Carolina,  27599,  United States; Not yet recruiting
      Greenville,  North Carolina,  27834,  United States; Recruiting
North Dakota
      Fargo,  North Dakota,  58103,  United States; Recruiting
Ohio
      Canton,  Ohio,  44718,  United States; Recruiting
Pennsylvania
      Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
Tennessee
      Knoxville,  Tennessee,  37916,  United States; Recruiting
      Memphis,  Tennessee,  38120,  United States; Recruiting
Texas
      Irving,  Texas,  75061,  United States; Recruiting
      Dallas,  Texas,  75390,  United States; Not yet recruiting
      Houston,  Texas,  77025,  United States; Recruiting
      Amarillo,  Texas,  79106,  United States; Recruiting
Utah
      Salt Lake City,  Utah,  84106,  United States; Recruiting
      Ogden,  Utah,  84403,  United States; Recruiting
Vermont
      Burlington,  Vermont,  05401,  United States; Recruiting
Virginia
      Richmond,  Virginia,  23230,  United States; Recruiting
      Danville,  Virginia,  24541,  United States; Recruiting
Washington
      Seattle,  Washington,  98104,  United States; Recruiting
      Tacoma,  Washington,  98405,  United States; Recruiting
West Virginia
      Charleston,  West Virginia,  25304,  United States; Recruiting
Canada, Manitoba
      Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Canada, Ontario
      Oshawa,  Ontario,  L1G 2B9,  Canada; Recruiting
      Mississauga,  Ontario,  L5B 1B8,  Canada; Recruiting
      Brampton,  Ontario,  L6W 3X4,  Canada; Recruiting
      Toronto,  Ontario,  M6S 1B5,  Canada; Recruiting
      London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Sudbury,  Ontario,  P3E 5J1,  Canada; Recruiting
Canada, Quebec
      Quebec City,  Quebec,  G1S 4L8,  Canada; Recruiting
      Montreal,  Quebec,  H1T 2M4,  Canada; Recruiting
      Montreal,  Quebec,  H2L 4M1,  Canada; Recruiting
      Montreal,  Quebec,  H3T 1E2,  Canada; Recruiting
      Montreal,  Quebec,  H4J 1C5,  Canada; Recruiting
      Fleurimont,  Quebec,  J1H 5N4,  Canada; Recruiting
Croatia
      Zagreb,  10000,  Croatia; Not yet recruiting
      Split,  21000,  Croatia; Not yet recruiting
      Osijek,  31000,  Croatia; Not yet recruiting
      Rijeka,  51000,  Croatia; Not yet recruiting
      Pula,  52000,  Croatia; Not yet recruiting
Czech Republic
      Praha 5,  150 08,  Czech Republic; Not yet recruiting
      Ceske Budejovice,  370 87,  Czech Republic; Not yet recruiting
      Brno,  656 63,  Czech Republic; Not yet recruiting
Denmark
      Koebenhavn,  2100,  Denmark; Not yet recruiting
      Odense,  5000,  Denmark; Not yet recruiting
      Aarhus,  8000,  Denmark; Not yet recruiting
      Aalborg,  9100,  Denmark; Not yet recruiting
France
      Besancon,  25030,  France; Not yet recruiting
      Toulouse,  31052,  France; Not yet recruiting
      Bordeaux,  33000,  France; Not yet recruiting
      Montpellier,  34298,  France; Not yet recruiting
      Saint-Etienne,  42100,  France; Not yet recruiting
      Angers,  49033,  France; Not yet recruiting
      Strasbourg,  67065,  France; Not yet recruiting
Hungary
      Budapest,  1032,  Hungary; Not yet recruiting
      Budapest,  1088,  Hungary; Not yet recruiting
      Budapest,  1096,  Hungary; Not yet recruiting
      Budapest,  1145,  Hungary; Not yet recruiting
      Tatabanya,  2800,  Hungary; Not yet recruiting
      Kecskemet,  6000,  Hungary; Not yet recruiting
      Szeged,  6720,  Hungary; Not yet recruiting
Ireland
      Waterford,  Ireland; Not yet recruiting
      Cork,  Ireland; Not yet recruiting
      Cork,  Ireland; Not yet recruiting
      Cork,  Ireland; Not yet recruiting
      Dublin,  D4,  Ireland; Not yet recruiting
      Dublin,  D7,  Ireland; Not yet recruiting
      Dublin,  D7,  Ireland; Not yet recruiting
      Dublin,  D8,  Ireland; Not yet recruiting
      Dublin,  D9,  Ireland; Not yet recruiting
      Galway,  Ireland; Not yet recruiting
      Limerick,  Ireland; Not yet recruiting
      Sligo,  Ireland; Not yet recruiting
Ireland, Offaly
      Tullamore,  Offaly,  Ireland; Not yet recruiting
Netherlands
      Delft,  2512,  Netherlands; Not yet recruiting
      Den Haag,  2512,  Netherlands; Not yet recruiting
      Den Haag,  2545,  Netherlands; Not yet recruiting
      Nieuwegein,  3435,  Netherlands; Not yet recruiting
      Utrecht,  3582,  Netherlands; Not yet recruiting
      Utrecht,  3584,  Netherlands; Not yet recruiting
      Amersfoort,  3818,  Netherlands; Not yet recruiting
      Eindhoven,  5623,  Netherlands; Not yet recruiting
      Sittard,  6131,  Netherlands; Not yet recruiting
      Maastricht,  6229,  Netherlands; Not yet recruiting
      HEERLEN,  6419,  Netherlands; Not yet recruiting
Russian Federation
      Moscow,  107005,  Russian Federation; Not yet recruiting
      Moscow,  115478,  Russian Federation; Not yet recruiting
      Moscow,  115478,  Russian Federation; Not yet recruiting
      St Petersburg,  197022,  Russian Federation; Not yet recruiting
      St Petersburg,  197758,  Russian Federation; Not yet recruiting
Spain
      Gerona,  17007,  Spain; Not yet recruiting
      San Sebastian,  20014,  Spain; Not yet recruiting
      Lledias,  25198,  Spain; Not yet recruiting
      Madrid,  28007,  Spain; Not yet recruiting
      Madrid,  28034,  Spain; Not yet recruiting
      Madrid,  28035,  Spain; Not yet recruiting
      Madrid,  28040,  Spain; Not yet recruiting
      Madrid,  28041,  Spain; Not yet recruiting
      Leganes,  28911,  Spain; Not yet recruiting
      Malaga,  29010,  Spain; Not yet recruiting
      Elche,  3203,  Spain; Not yet recruiting
      Oviedo,  33006,  Spain; Not yet recruiting
      Valencia,  46010,  Spain; Not yet recruiting
      Zaragoza,  50009,  Spain; Not yet recruiting
      Palma de Mallorca,  7014,  Spain; Not yet recruiting
      Barcelona,  8036,  Spain; Not yet recruiting
      Badalona,  8916,  Spain; Not yet recruiting
United Kingdom
      London,  HA6 2RN,  United Kingdom; Not yet recruiting
      London,  SW17 OQT,  United Kingdom; Not yet recruiting
United Kingdom, Essex
      Chelmsford,  Essex,  CM1 7ET,  United Kingdom; Not yet recruiting
United Kingdom, Lancashire
      Manchester,  Lancashire,  M20 4BX,  United Kingdom; Not yet recruiting
United Kingdom, South Yorkshire
      Sheffield,  South Yorkshire,  S10 2SJ,  United Kingdom; Not yet recruiting
United Kingdom, Wales
      Newport,  Wales,  NP20 2UB,  United Kingdom; Not yet recruiting
United Kingdom, West Midlands
      Birmingham,  West Midlands,  B18 7QH,  United Kingdom; Not yet recruiting
United Kingdom, Yorkshire
      Huddersfield,  Yorkshire,  HD3 3EA,  United Kingdom; Not yet recruiting

Study ID Numbers:  EGF30008
Record last reviewed:  October 2004
Record first received:  November 24, 2003
ClinicalTrials.gov Identifier:  NCT00073528
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10