An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01215123
First received: September 27, 2010
Last updated: January 25, 2016
Last verified: January 2016
Results First Received: January 25, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Breast Cancer
Intervention: Drug: Bevacizumab

  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
The study duration is January 2010 (first data collected) to July 2012 (last data collected). In this study, medical records of participants evaluated between 2008 and 2012 were reviewed.

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
Bevacizumab Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.

Participant Flow:   Overall Study
    Bevacizumab  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  



  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.
All enrolled participants

Reporting Groups
  Description
Bevacizumab Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.

Baseline Measures
    Bevacizumab  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Mean (Standard Deviation)
  54  (9)  
Gender  
[units: participants]
 
Female     28  
Male     0  



  Outcome Measures
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1.  Primary:   Time to Disease Progression (TDP)   [ Time Frame: Up to a maximum of 36.4 months ]

2.  Secondary:   Treatment Duration: Number of Bevacizumab Cycles   [ Time Frame: Up to a maximum of 36.4 months ]


  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-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01215123     History of Changes
Other Study ID Numbers: ML25100
Study First Received: September 27, 2010
Results First Received: January 25, 2016
Last Updated: January 25, 2016
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica