Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00030537
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Center for Cancer Research
🇺🇸Bethesda, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Center for Cancer Research🇺🇸Bethesda, Maryland, United States