Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
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An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)
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).
Adequate kidney and liver function
Adequate bone marrow function
Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.)
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.
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.