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Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer

NCT00503841 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-04-30

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.

PURPOSE: This clinical trial is studying how well erlotinib works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.

Conditions

Interventions

DRUG

erlotinib hydrochloride

Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.

OTHER

immunohistochemistry staining method

Assessed at the time of the initial biopsy and at the time of surgery.

OTHER

laboratory biomarker analysis

Correlative studies

PROCEDURE

biopsy

14 days prior to surgery

PROCEDURE

conventional surgery

14 days after taking study drug erlotinib hydrochloride.

PROCEDURE

neoadjuvant therapy

14 days after taking study drug erlotinib hydrochloride.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Elaina M. Gartner, MD · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-02-28
Completion
2010-05-31

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 NCT00503841 on ClinicalTrials.gov