Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00284180
First received: January 27, 2006
Last updated: July 9, 2013
Last verified: July 2013
Results First Received: March 25, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Neoplasms
Breast Cancer
Interventions: Drug: Vinflunine
Drug: Trastuzumab

  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
No text entered.

Reporting Groups
  Description
Vinflunine Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
Vinflunine/Trastuzumab Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2

Participant Flow:   Overall Study
    Vinflunine     Vinflunine/Trastuzumab  
STARTED     11     21  
COMPLETED     11     17  
NOT COMPLETED     0     4  



  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
Vinflunine Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
Vinflunine/Trastuzumab Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
Total Total of all reporting groups

Baseline Measures
    Vinflunine     Vinflunine/Trastuzumab     Total  
Number of Participants  
[units: participants]
  11     21     32  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 47 to 78 )  
  58  
  ( 35 to 78 )  
  59  
  ( 35 to 78 )  
Gender  
[units: participants]
     
Female     11     21     32  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     11     21     32  



  Outcome Measures

1.  Primary:   Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 877-691-7274
e-mail: ASKSARAH@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00284180     History of Changes
Other Study ID Numbers: SCRI BRE 89
Study First Received: January 27, 2006
Results First Received: March 25, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration