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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00633750
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    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.
  • TUNEL assay — GENETIC
    Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
  • protein expression analysis — GENETIC
    Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
  • immunohistochemistry staining method — OTHER
    Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
  • laboratory biomarker analysis — OTHER
    Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
  • liquid chromatography — OTHER
    Used to determine blood plasma levels of Erlotinib on the day of surgery
  • mass spectrometry — OTHER
    Used to determine blood plasma levels of Erlotinib on the day of surgery
  • matrix-assisted laser desorption ionization mass spectrometry — OTHER
    After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
  • therapeutic conventional surgery — PROCEDURE
    Surgical treatment will occur within 24-hours following completion of therapy.

Study Details

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.

Key Dates

First listed
Mar 12, 2008
Start date
Aug 31, 2002
Status verified
Jul 2012
Primary completion
Oct 31, 2007
Completion
Oct 31, 2007

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tarceva

Primary Outcome Measure

Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva [ Time Frame: 5-14 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama, BirminghamBirminghamAlabama35249-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514-
Meharry Medical CollegeNashvilleTennessee37208-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama, Birmingham· Birmingham, ALDana-Farber Cancer Institute· Boston, MALineberger Comprehensive Cancer Center· Chapel Hill, NCMeharry Medical College· Nashville, TNVanderbilt-Ingram Cancer Center· Nashville, TN

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