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A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

This study has been terminated.
(The sample for statistical analysis of results could not be recruited within the specified timeframe upon retirement of the original principal investigator.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576901
First received: December 18, 2007
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: bevacizumab [Avastin]
Drug: Docetaxel
Drug: Xeloda

  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
Bevacizumab+Docetaxel+Capecitabine Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m^2), IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.

Participant Flow:   Overall Study
    Bevacizumab+Docetaxel+Capecitabine  
STARTED     23  
COMPLETED     20  
NOT COMPLETED     3  
Withdrawal by Subject                 1  
Disease course                 1  
Protocol Violation                 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.
Intent-to-treat (ITT) population. The ITT population included all enrolled participants.

Reporting Groups
  Description
Bevacizumab+Docetaxel+Capecitabine Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.

Baseline Measures
    Bevacizumab+Docetaxel+Capecitabine  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Mean ± Standard Deviation
  51.96  ± 11.51  
Gender  
[units: participants]
 
Female     23  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving Pathological Complete Response (pCR)   [ Time Frame: At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks) ]

2.  Secondary:   Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)   [ Time Frame: Day 1 of Cycles 1-6 ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: Cycles 1-6 ]

4.  Secondary:   Overall Survival   [ Time Frame: Cycles 1-6 ]

5.  Secondary:   Percentage of Participants Undergoing Breast-Conserving Surgery   [ Time Frame: Following Cycle 6 ]


  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 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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576901     History of Changes
Other Study ID Numbers: ML20561
Study First Received: December 18, 2007
Results First Received: May 16, 2014
Last Updated: July 17, 2014
Health Authority: Spain: Agencia Espanola del Medicamento