Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(All enrolled participants were screen failures, no data were collected for outcome measures.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elaina Gartner, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00503841
First received: July 17, 2007
Last updated: March 27, 2013
Last verified: March 2013
Results First Received: January 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
  Hide 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
  Description
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  
STARTED     44  
COMPLETED     0  
NOT COMPLETED     44  
All screen failures                 44  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Erlotinib Hydrochloride If participants would have went onto study they would 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.

Baseline Measures
    Erlotinib Hydrochloride  
Number of Participants  
[units: participants]
  44  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     37  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 12.52769  
Gender  
[units: participants]
 
Female     44  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     44  



  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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   Yes


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No patients were actually treated on the study.

Reporting Groups
  Description
Erlotinib Hydrochloride Patients will be instructed to take tablets once daily.Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.The day of planned surgical resection of the invasive breast cancer will be considered day 0.

Serious Adverse Events
    Erlotinib Hydrochloride  
Total, serious adverse events    
# participants affected / at risk     0/0 (0.00%)  




  Other Adverse Events


  Limitations and Caveats
  Hide 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