The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Condition	Treatment or Intervention	Phase
Metastatic breast cancer	Drug: GW572016	Phase II

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

Criteria

Inclusion criteria:

• Signed informed consent
• No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.
• Refractory Stage IIIb or IV breast cancer
• HER2/neu tumor overexpression
• Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.
• Tumor tissue available for testing.
• 2 weeks since treatment with Herceptin (alone or in combination).
• Able to swallow and retain oral medication
• Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan) or Echocardiogram.
• Adequate kidney and liver function
• Adequate bone marrow function

Exclusion criteria:

• Prior regimens did not include Herceptin.
• Pregnant or lactating.
• 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.
• Severe cardiovascular disease or cardiac disease requiring a device.
• Active infection.
• Brain metastases.
• Concurrent cancer therapy or investigational therapy.
• Use of oral or IV steroids.
• Unresolved or unstable serious toxicity from prior therapy.
• Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.

California
      Los Angeles,  California,  90067,  United States; No longer recruiting
      Los Angeles,  California,  90095,  United States; Recruiting
      Poway,  California,  92064,  United States; Recruiting
      San Diego,  California,  92108,  United States; Recruiting
Connecticut
      Torrington,  Connecticut,  06790,  United States; No longer recruiting
Florida
      Miami,  Florida,  33138,  United States; No longer recruiting
      Plantation,  Florida,  33324,  United States; Recruiting
      Boca Raton,  Florida,  33428,  United States; No longer recruiting
      Lakeland,  Florida,  33805,  United States; No longer recruiting
      Fort Myers,  Florida,  33901,  United States; Recruiting
Georgia
      Savannah,  Georgia,  31405,  United States; No longer recruiting
Illinois
      Arlington Heights,  Illinois,  60004,  United States; No longer recruiting
      Park Ridge,  Illinois,  60068,  United States; Recruiting
      Skokie,  Illinois,  60076,  United States; Terminated
      Skokie,  Illinois,  60077,  United States; Recruiting
Iowa
      Des Moines,  Iowa,  50314,  United States; No longer recruiting
      Bettendorf,  Iowa,  52722,  United States; No longer recruiting
Louisiana
      Metairie,  Louisiana,  70006,  United States; Recruiting
      Lafayette,  Louisiana,  70506,  United States; No longer recruiting
Maine
      Scarborough,  Maine,  04074,  United States; No longer recruiting
Maryland
      Baltimore,  Maryland,  21201,  United States; Recruiting
Massachusetts
      Wellesley,  Massachusetts,  02481,  United States; No longer recruiting
Michigan
      Royal Oak,  Michigan,  48073,  United States; No longer recruiting
Missouri
      St. Charles,  Missouri,  63301,  United States; No longer recruiting
      St. Joseph,  Missouri,  64507,  United States; No longer recruiting
      Columbia,  Missouri,  65201,  United States; Recruiting
Montana
      Billings,  Montana,  59101,  United States; No longer recruiting
      Great Falls,  Montana,  59405,  United States; No longer recruiting
New Hampshire
      Hooksett,  New Hampshire,  03106-2505,  United States; Recruiting
New Jersey
      Summit,  New Jersey,  07091,  United States; No longer recruiting
      Paramus,  New Jersey,  07652,  United States; No longer recruiting
      Morristown,  New Jersey,  07962,  United States; No longer recruiting
      East Brunswick,  New Jersey,  08816,  United States; No longer recruiting
New York
      New York,  New York,  10029,  United States; No longer recruiting
      Armonk,  New York,  10504,  United States; No longer recruiting
      White Plains,  New York,  10601,  United States; No longer recruiting
      Great Neck,  New York,  11023,  United States; No longer recruiting
North Carolina
      Greensboro,  North Carolina,  27403,  United States; No longer recruiting
      Goldsboro,  North Carolina,  27534,  United States; No longer recruiting
      Durham,  North Carolina,  27710,  United States; Recruiting
      Greenville,  North Carolina,  27834,  United States; No longer recruiting
      Charlotte,  North Carolina,  28203,  United States; No longer recruiting
      Hickory,  North Carolina,  28602,  United States; No longer recruiting
North Dakota
      Fargo,  North Dakota,  58104,  United States; No longer recruiting
Ohio
      Cincinnati,  Ohio,  45219,  United States; No longer recruiting
Oklahoma
      Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Tulsa,  Oklahoma,  74136,  United States; Recruiting
Pennsylvania
      Pittsburgh,  Pennsylvania,  15213,  United States; Not yet recruiting
      Kingston,  Pennsylvania,  18704,  United States; No longer recruiting
South Carolina
      Columbia,  South Carolina,  29201,  United States; No longer recruiting
Tennessee
      Memphis,  Tennessee,  36104,  United States; Terminated
      Nashville,  Tennessee,  37203,  United States; No longer recruiting
      Nashville,  Tennessee,  37205,  United States; Recruiting
      Memphis,  Tennessee,  38120,  United States; Recruiting
      Germantown,  Tennessee,  38138,  United States; Terminated
Texas
      Houston,  Texas,  77025,  United States; Recruiting
Virginia
      Salem,  Virginia,  24153,  United States; Recruiting
Washington
      Seattle,  Washington,  98101,  United States; No longer recruiting
      Yakima,  Washington,  98902,  United States; No longer recruiting

Study ID Numbers:  EGF20002
Record last reviewed:  September 2004
Record first received:  August 26, 2002
ClinicalTrials.gov Identifier:  NCT00044330
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10