Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Breast Cancer 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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00030537
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: November 2001
• Completion date: March 2003