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A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00089479
First received: August 5, 2004
Last updated: December 19, 2012
Last verified: December 2012
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: capecitabine [Xeloda]
Drug: Taxotere

  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
AC Then T Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
AC Then XT Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles

Participant Flow:   Overall Study
    AC Then T     AC Then XT  
STARTED     1304     1307  
Received Treatment     1305 [1]   1283 [2]
COMPLETED     973 [3]   1018 [3]
NOT COMPLETED     331     289  
Death                 108                 75  
Withdrawal by Subject                 86                 107  
Lost to Follow-up                 137                 107  
[1] Safety Population (includes 19 patients randomized to ACXT, who received ACT)
[2] Safety Population (includes 5 patients randomized to ACT, who received ACXT)
[3] total includes Completed and Alive in follow-up



  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.
No text entered.

Reporting Groups
  Description
AC Then T Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
AC Then XT Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
Total Total of all reporting groups

Baseline Measures
    AC Then T     AC Then XT     Total  
Number of Participants  
[units: participants]
  1304     1307     2611  
Age  
[units: years]
Mean ± Standard Deviation
  51.2  ± 8.81     50.6  ± 9.19     50.9  ± 9.00  
Gender  
[units: participants]
     
Female     1304     1307     2611  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Disease Free Survival [Number of Events]   [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

2.  Primary:   Disease Free Survival [Time to Event]   [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

3.  Secondary:   Overall Survival [Number of Events]   [ Time Frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. ]

4.  Secondary:   Overall Survival [Time to Event]   [ Time Frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. ]

5.  Secondary:   Breast Cancer Free Survival [Number of Events]   [ Time Frame: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years . ]

6.  Secondary:   Breast Cancer Free Survival [Time to Event]   [ Time Frame: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

7.  Secondary:   Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]   [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

8.  Secondary:   Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event   [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

9.  Secondary:   Disease Free Survival Including Any New Cancer as Event [Number of Events]   [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. ]

10.  Secondary:   Disease Free Survival Including Any New Cancer as Event [Time to Event]   [ Time Frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 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: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00089479     History of Changes
Other Study ID Numbers: NO17629
Study First Received: August 5, 2004
Results First Received: March 31, 2011
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration