An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO) (VIRGO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00726661
First received: July 30, 2008
Last updated: May 23, 2016
Last verified: May 2016
Results First Received: April 5, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Breast Cancer

  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
This study was conducted from 01 June 2008 to 31 December 2012 in the United States. A total of 1287 participants were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 1287 participants, 20 were not eligible for the study and were excluded. Of 1267 participants, 832 were observed in Chemotherapy cohort and 435 were observed in Hormonal Therapy cohort.

Reporting Groups
  Description
Chemotherapy Cohort Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
Hormonal Therapy Cohort Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).

Participant Flow:   Overall Study
    Chemotherapy Cohort     Hormonal Therapy Cohort  
STARTED     832     435  
COMPLETED     18     17  
NOT COMPLETED     814     418  
Lost to Follow-up                 36                 11  
Withdrawal by Subject                 17                 13  
Trial terminated by sponsor                 214                 187  
Death                 475                 159  
Physician Decision                 25                 13  
Not specified                 47                 35  



  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.
Baseline characteristics was analyzed for all enrolled participants in respective individual groups (CT Cohort and HT Cohort); therefore, the data for 'mean age' for total population is not applicable for this study.

Reporting Groups
  Description
Chemotherapy Cohort Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
Hormonal Therapy Cohort Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
Total Total of all reporting groups

Baseline Measures
    Chemotherapy Cohort     Hormonal Therapy Cohort     Total  
Number of Participants  
[units: participants]
  832     435     1267  
Age  
[units: years]
Mean (Standard Deviation)
  57.40  (11.98)     63.99  (12.57)     59.66  (12.58)  
Gender  
[units: participants]
     
Female     826     434     1260  
Male     6     1     7  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: Approximately 4.5 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Approximately 4.5 years ]

3.  Secondary:   Number of Participants With Tumor Response   [ Time Frame: Approximately 4.5 years ]

4.  Secondary:   Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation   [ Time Frame: Approximately 4.5 years ]

5.  Secondary:   Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death   [ Time Frame: Approximately 4.5 years ]

6.  Secondary:   Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy   [ Time Frame: Approximately 4.5 years ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00726661     History of Changes
Other Study ID Numbers: AVF4349n
Study First Received: July 30, 2008
Results First Received: April 5, 2016
Last Updated: May 23, 2016
Health Authority: United States: Institutional Review Board