A Pilot Study to Evaluate Epidermal Growth Factor Receptor Signaling After Treatment With Oral OSI-774 in Patients With Locally Advanced or Metastatic Breast Cancer
- 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
- Determine the toxicity of this drug in these patients.
- Determine the response duration and time to progression in patients treated with this
- 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
Primary Purpose: Treatment
Antoinette R. Tan, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Center for Cancer Research||Bethesda, Maryland 20892|