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Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer

This study has been terminated.
(Poor Accrual)
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00739063
First received: August 19, 2008
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Tarceva

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: July 22, 2008 to November 03, 2010. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated early due to slow accrual. Eleven patients were enrolled, only three received treatment.

Reporting Groups
  Description
Tarceva Daily Tarceva oral 150 mg daily.

Participant Flow:   Overall Study
    Tarceva Daily  
STARTED     11  
COMPLETED     3  
NOT COMPLETED     8  
Screen failures                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Tarceva Daily Tarceva oral 150 mg daily.

Baseline Measures
    Tarceva Daily  
Number of Participants  
[units: participants]
 		  11  
Age  
[units: years]
Mean ( Full Range ) 		  52  
  ( 37 to 82 )  
Gender  
[units: participants]
 		 
Female     11  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     11  



  Outcome Measures

1.  Primary:   Time to Progression (TTP)   [ Time Frame: Baseline to disease progression, up to 22 months with follow up. ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Ana Gonzalez-Angulo, MD, MS / Associate Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00739063     History of Changes
Other Study ID Numbers: 2006-0613
Study First Received: August 19, 2008
Results First Received: December 21, 2011
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board