XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01777945
First received: January 25, 2013
Last updated: July 12, 2016
Last verified: February 2016
Results First Received: April 12, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Breast Cancer
Interventions: Drug: capecitabine
Drug: docetaxel

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
46 participants were enrolled in the study and included in safety assessments. 45 participants were included in other assessments.

Reporting Groups
  Description
Participants Receiving Capecitabine/Docetaxel Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.

Participant Flow:   Overall Study
    Participants Receiving Capecitabine/Docetaxel  
STARTED     46  
Evaluable Participants     45  
COMPLETED     46  
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 participants were female.

Reporting Groups
  Description
Participants Receiving Capecitabine/Docetaxel Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.

Baseline Measures
    Participants Receiving Capecitabine/Docetaxel  
Number of Participants  
[units: participants]
  45  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     15  
Age  
[units: years]
Mean (Standard Deviation)
  58.58  (11.359)  
Gender  
[units: participants]
 
Female     45  
Male     0  
Region of Enrollment  
[units: participants]
 
Hungary     45  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: approximately 2 years ]

2.  Secondary:   Time to Treatment Failure   [ Time Frame: approximately 2 years ]

3.  Secondary:   Overall Response Rate   [ Time Frame: approximately 2 years ]

4.  Secondary:   Clinical Benefit Rate   [ Time Frame: approximately 2 years ]

5.  Secondary:   Duration of Treatment With Xeloda   [ Time Frame: approximately 2 years ]

6.  Secondary:   Percentage of Capecitabine Dose Modifications   [ Time Frame: approximately 2 years ]

7.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: approximately 2 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: Medical Communications
Organization: Hoffmann-La Roche
phone: 1-800-821-8590



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01777945     History of Changes
Other Study ID Numbers: ML28505
Study First Received: January 25, 2013
Results First Received: April 12, 2016
Last Updated: July 12, 2016
Health Authority: Hungary: National Institute of Pharmacy