Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00030537|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: erlotinib hydrochloride||Phase 2|
- 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 (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||November 2001|
|Actual Study Completion Date :||March 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030537
|United States, Maryland|
|Center for Cancer Research|
|Bethesda, Maryland, United States, 20889-5101|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Antoinette R. Tan, MD||National Cancer Institute (NCI)|