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Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paula Silverman, PhD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00054275
First received: February 5, 2003
Last updated: December 23, 2012
Last verified: December 2012
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: docetaxel
Drug: erlotinib hydrochloride

  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
Patients recruited from University Hospitals and its satellite hospitals from 12/4/2002 through 9/22/2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Docetaxel and OSI-774 docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily

Participant Flow:   Overall Study
    Docetaxel and OSI-774  
STARTED     39  
COMPLETED     28  
NOT COMPLETED     11  
Withdrawal by Subject                 4  
Adverse Event                 5  
Progressive disease in cycle 1                 1  
Physician Decision                 1  



  Baseline Characteristics
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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
Docetaxel and OSI-774 docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily

Baseline Measures
    Docetaxel and OSI-774  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Median ( Full Range )
  51  
  ( 28 to 78 )  
Gender  
[units: participants]
 
Female     39  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     39  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000   [ Time Frame: after 6 course (6 months) of combination therapy ]

2.  Secondary:   Progression Free Survival(PFS)   [ Time Frame: 3 years ]

3.  Secondary:   Overall Survival as of 2008   [ Time Frame: 5 yrs ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paula Silverman, MD
Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
phone: 216-844-3951
e-mail: paula.silverman@uhhospitals.org


No publications provided


Responsible Party: Paula Silverman, PhD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00054275     History of Changes
Other Study ID Numbers: CWRU1102, P30CA043703, 07-02-14M, CASE-CWRU-1102
Study First Received: February 5, 2003
Results First Received: February 21, 2012
Last Updated: December 23, 2012
Health Authority: United States: Food and Drug Administration