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Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy

This study has been terminated.
(change in development plan, not due to safety concerns.)
Sponsor:
Collaborator:
Fresenius Biotech North America
Information provided by:
Fresenius Biotech GmbH
ClinicalTrials.gov Identifier:
NCT00522457
First received: August 28, 2007
Last updated: April 28, 2011
Last verified: April 2011
History of Changes
Results First Received: March 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Breast Cancer
Advanced Breast Cancer
Intervention: Drug: ertumaxomab

  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
Open-label phase 2 study evaluating the efficacy and safety of ertumaxomab for the treatment of metastatic breast cancer tumors. Ertumaxomab will be administered 3 times at 7 day intervals by constant rate 3 hour intravenous (IV) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7±1)and 100 µg(day14±1)(flat doses).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were required to complete screening procedures and up to five treatment visits.

Reporting Groups
  Description
Ertumaxomab No text entered.

Participant Flow:   Overall Study
    Ertumaxomab  
STARTED     19  
COMPLETED     1  
NOT COMPLETED     18  
Due to disease progression                 16  
Adverse Event                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Ertumaxomab No text entered.

Baseline Measures
    Ertumaxomab  
Number of Participants  
[units: participants]
 		  19  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     19  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     12  
Canada     7  



  Outcome Measures
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1.  Primary:   Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)   [ Time Frame: patients are monitored for 6 months ]
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2.  Secondary:   Duration of Response   [ Time Frame: patients are monitored for 6 months ]
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3.  Secondary:   Clinical Benefit Rate   [ Time Frame: patients are monitored for 6 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
The study was prematurely terminated. This decision was based on strategic changes in the company's research and development program and resulted in limited patient data.  


Results Point of Contact:  
Name/Title: Manager of Regulatory Affairs
Organization: Fresenius Biotech North America
phone: 781-699-4652
e-mail: bao.le@fresenius-biotech.com


Publications:


Responsible Party: Manager of Regulatory Affairs, Fresenius Biotech North America
ClinicalTrials.gov Identifier: NCT00522457     History of Changes
Other Study ID Numbers: IV-ERT-BC-04
Study First Received: August 28, 2007
Results First Received: March 1, 2011
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada