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Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery

NCT00633750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-09-05

Study results available
· View outcomes & findings →

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with breast cancer that can be removed by surgery.

Conditions

Interventions

DRUG

erlotinib hydrochloride

Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.

GENETIC

TUNEL assay

Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens

GENETIC

protein expression analysis

Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens

OTHER

immunohistochemistry staining method

Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens

OTHER

laboratory biomarker analysis

Used to assess level of expression of genetic markers in pre-therapy and surgical specimens

OTHER

liquid chromatography

Used to determine blood plasma levels of Erlotinib on the day of surgery

OTHER

mass spectrometry

Used to determine blood plasma levels of Erlotinib on the day of surgery

OTHER

matrix-assisted laser desorption ionization mass spectrometry

After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue

PROCEDURE

therapeutic conventional surgery

Surgical treatment will occur within 24-hours following completion of therapy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Carlos L. Arteaga, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633750 on ClinicalTrials.gov