Trial Information

Summary: Study Comparing GW572016 And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer.

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.

Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)

• Signed informed consent
• Stage IIIb or IV breast cancer
• Tumors that are estrogen and/or progesterone receptor-positive
• Post-menopausal women
• 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
• Adequate kidney, liver, and bone marrow function

Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.)

• Pre-menopausal, pregnant, or lactating females
• Received prior therapy for advanced or metastatic breast cancer
• 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
• Use of oral or intravenous (IV) steroids
• Unresolved or unstable serious toxicity from prior therapy

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

Click Here to find out if you might qualify or visit www.findclinicalstudy.com for more information.

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Trial listings updated: June 1, 2008 at 5:43:59 AM