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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01215123
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Breast Cancer
Intervention: Drug: Bevacizumab

  Participant Flow

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
No text entered.

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

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 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (9) 
Gender 
[Units: Participants]
 
Female   28 
Male   0 


  Outcome Measures

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

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.


  More Information

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
First Submitted: September 27, 2010
First Posted: October 6, 2010
Results First Submitted: January 25, 2016
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016