Trial Information

Summary: Paclitaxel With Or Without GW572016 As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer.

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.

Inclusion Criteria (a subject must meet the following criteria in order to be considered eligible to participate in this study):

• 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 (a subject cannot meet the following criteria in order to be considered eligible to participate in this study):

• 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 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.

Healthy Volunteers: no
Gender: Female
Minimum Age: 18 Years
Maximum Age: N/A

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Trial listings updated: June 1, 2008 at 5:44:02 AM