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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT00503841
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    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.
  • immunohistochemistry staining method — OTHER
    Assessed at the time of the initial biopsy and at the time of surgery.
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • biopsy — PROCEDURE
    14 days prior to surgery
  • conventional surgery — PROCEDURE
    14 days after taking study drug erlotinib hydrochloride.
  • neoadjuvant therapy — PROCEDURE
    14 days after taking study drug erlotinib hydrochloride.

Study Details

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.

Key Dates

First listed
Jul 19, 2007
Start date
Dec 31, 2007
Status verified
Apr 2019
Primary completion
Feb 28, 2010
Completion
May 31, 2010

Study Design

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

Arms

  • Experimental: 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.

Primary Outcome Measure

Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer [ Time Frame: Baseline and day 0 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-1379-

Find similar trials in Detroit, MI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Barbara Ann Karmanos Cancer Institute· Detroit, MI

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