RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.
OBJECTIVES: * Determine whether a change in epidermal growth factor receptor (EGFR) phosphorylation is detected in tumors of patients with locally advanced or metastatic breast cancer treated with erlotinib. * Determine whether a change in other parameters of signal transduction that are downstream of EGFR (ERK and AKT) is detected in tumors of patients treated with this drug. * Determine the toxicity of this drug in these patients. * Determine the response duration and time to progression in patients treated with this drug. * Correlate EGFR phosphorylation level with clinical findings and time to progression in patients treated with this drug. * Correlate the pharmacokinetics of this drug with a change in EGFR phosphorylation in tumor biopsies of these patients. OUTLINE: Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed within 4 weeks. PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 7-10 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Center for Cancer Research
Bethesda, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
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