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A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer

This study has been terminated.
(Sponsor funding stopped)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier:
NCT00674206
First received: May 6, 2008
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
Results First Received: March 30, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Gemcitabine
Drug: Oxaliplatin

  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
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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
Single Arm Study All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.

Participant Flow:   Overall Study
    Single Arm Study  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Single Arm Study All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.

Baseline Measures
    Single Arm Study  
Number of Participants  
[units: participants]
 		  6  
Age  
[units: participants]
Median ( Full Range ) 		  55  
  ( 32 to 66 )  
Gender  
[units: participants]
 		 
Female     6  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     6  



  Outcome Measures
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1.  Primary:   Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.   [ Time Frame: 8 weeks ]
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2.  Secondary:   Overall Survival From Time of Study Entry   [ Time Frame: 132 weeks ]
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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:  
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
Early termination of the study due to slow accrual  


Results Point of Contact:  
Name/Title: Dr. Amelia Zelnak
Organization: Emory University
phone: 404-778-1900
e-mail: amelia.zelnak@emoryhealthcare.org


No publications provided


Responsible Party: Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier: NCT00674206     History of Changes
Other Study ID Numbers: 7792
Study First Received: May 6, 2008
Results First Received: March 30, 2012
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board