Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030537
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2002-02-14
Brief Title:
Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-C-0061 | None | None | None |
| NCI-5403 | None | None | None |