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A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00846027
First received: February 17, 2009
Last updated: July 9, 2014
Last verified: July 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Bevacizumab
Drug: Paclitaxel
Drug: Gemcitabine

  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 + Paclitaxel + Gemcitabine Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Participant Flow:   Overall Study
    Bevacizumab + Paclitaxel + Gemcitabine  
STARTED     90  
Received Treatment     83  
COMPLETED     0  
NOT COMPLETED     90  
Death                 3  
Disease Progression                 30  
Toxicity                 12  
Patient Decision                 7  
Investigator Discretion                 29  
Protocol Violation                 2  
Subject Not Treated                 7  



  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 population: All participants enrolled in the study.

Reporting Groups
  Description
Bevacizumab + Paclitaxel + Gemcitabine Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Baseline Measures
    Bevacizumab + Paclitaxel + Gemcitabine  
Number of Participants  
[units: participants]
  90  
Age  
[units: years]
Mean ± Standard Deviation
  52.20  ± 12.48  
Gender  
[units: participants]
 
Female     89  
Male     1  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ]

2.  Secondary:   Percentage of Participants With an Objective Response   [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ]

3.  Secondary:   Duration of the Objective Response   [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ]

4.  Secondary:   Overall Survival   [ Time Frame: Baseline to the end of the study (up to 2 years 10 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


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00846027     History of Changes
Other Study ID Numbers: ML21999, 2008-003657-32
Study First Received: February 17, 2009
Results First Received: May 27, 2014
Last Updated: July 9, 2014
Health Authority: Spain: Agencia Espanola del Medicamento