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Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054132
First received: February 5, 2003
Last updated: June 23, 2017
Last verified: June 2017
Results First Received: March 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Recurrent Breast Carcinoma
Stage IV Breast Cancer
Interventions: Biological: Bevacizumab
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Erlotinib Hydrochloride, Bevacizumab) Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Erlotinib Hydrochloride, Bevacizumab)
STARTED   38 
COMPLETED   37 
NOT COMPLETED   1 
Not Treated                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
Treatment (Erlotinib Hydrochloride, Bevacizumab) Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (Erlotinib Hydrochloride, Bevacizumab) 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      34  89.5% 
>=65 years      4  10.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      38 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   38 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Level of EGFR Expression   [ Time Frame: Up to 12 years ]

2.  Primary:   Response Rate, Defined as Complete Response (CR) + Partial Response (PR), Using the Response Evaluation Criteria in Solid Tumors   [ Time Frame: Up to 12 years ]

3.  Secondary:   Duration of Response   [ Time Frame: From the time measurement criteria are met for CR and PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years ]

4.  Secondary:   Time to Progression   [ Time Frame: From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years ]

5.  Secondary:   Number of Patients Evaluated for Toxicity   [ Time Frame: up to 12 years ]

6.  Secondary:   Participants With Duration of Stable Disease Greater Than or Equal to 6 Months   [ Time Frame: From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years ]

7.  Other Pre-specified:   HER2 Status   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Percentage of Cells Staining Positive for EGFR   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Percentage of Cells Staining Positive for Human Epidermal Growth Factor Receptor 3 (HER3)   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Percentage of Cells Staining Positive for Marker of Proliferation Ki-67 (Ki-67)   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Percentage of Cells Staining Positive for p27   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   Percentage of Cells Staining Positive for Phosphorylated-mitogen-activated Protein Kinase (MAP) Kinase   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   Percentage of Cells Staining Positive for Phosphorylated-v-akt Murine Thymoma Viral Oncogene Homolog 1 (Akt)   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Other Pre-specified:   Percentage of Cells Staining Positive for Tumor Protein p53 (p53)   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Other Pre-specified:   Percentage of Cells Staining Positive for VEGF   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

16.  Other Pre-specified:   Percentage of Cells Staining Positive for VEGF Receptor (VEGFR)-1   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

17.  Other Pre-specified:   Percentage of Cells Staining Positive for VEGFR-2   [ Time Frame: Up to 12 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Maura Dickler
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4560
e-mail: dicklerm@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054132     History of Changes
Other Study ID Numbers: NCI-2013-02225
NCI-2013-02225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000269900
02-119
MSKCC-02119
NCI-5761
02-119 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
5761 ( Other Identifier: CTEP )
N01CM17105 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
Study First Received: February 5, 2003
Results First Received: March 9, 2016
Last Updated: June 23, 2017