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

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ClinicalTrials.gov Identifier: NCT00503841
Recruitment Status : Terminated (All enrolled participants were screen failures, no data were collected for outcome measures.)
First Posted : July 19, 2007
Results First Posted : February 12, 2013
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: erlotinib hydrochloride
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: conventional surgery
Procedure: neoadjuvant therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
44 participants signed consent starting 1-9-08 and recruitment ending with the last participant signing on 1-19-10. All participants enrolled onto screening portion of study, but none were ever put onto the "treatment" portion of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants that signed consent were screen failures.

Reporting Groups
Erlotinib Hydrochloride

If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis

Treatment continues in the absence of disease progression or unacceptable toxicity.

Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)

Participant Flow:   Overall Study
    Erlotinib Hydrochloride
All screen failures                44 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer   [ Time Frame: Baseline and day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)   [ Time Frame: Baseline and day 0 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride   [ Time Frame: At day -7, prior to surgery, and 1 week post-surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information