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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054275
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : March 13, 2012
Last Update Posted : February 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paula Silverman, MD, Case Comprehensive Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: docetaxel
Drug: erlotinib hydrochloride

  Participant Flow

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
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
Withdrawal by Subject                4 
Adverse Event                5 
Progressive disease in cycle 1                1 
Physician Decision                1 

  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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (28 to 78) 
[Units: Participants]
Female   39 
Male   0 
Region of Enrollment 
[Units: Participants]
United States   39 

  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

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

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

Responsible Party: Paula Silverman, MD, Case Comprehensive Cancer Center Identifier: NCT00054275     History of Changes
Other Study ID Numbers: CWRU1102
P30CA043703 ( U.S. NIH Grant/Contract )
07-02-14M ( Other Identifier: University Hospitals IRB )
CASE-CWRU-1102 ( Other Identifier: Case Comprehensive Cancer Center )
First Submitted: February 5, 2003
First Posted: February 6, 2003
Results First Submitted: February 21, 2012
Results First Posted: March 13, 2012
Last Update Posted: February 17, 2016