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Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

This study has been completed.
Sponsor:
Collaborator:
Cancer International Research Group (CIRG)
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00688740
First received: May 29, 2008
Last updated: February 14, 2011
Last verified: February 2011
Results First Received: January 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Docetaxel
Drug: 5-fluorouracil
Drug: Doxorubicin
Drug: Cyclophosphamide

  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
Between June 1997 and June 1999, 1491 women from 20 countries were enrolled in the study. The last patient last visit occurred in January 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eleven women (1 who had been randomly assigned to receive TAC and 10 assigned to receive FAC) did not receive any treatment for the following reasons: 8 withdrew consent, 1 was lost to follow-up, and 2 did not receive treatment for other reasons. In total 1480 patients (744 in the TAC group and 736 in the FAC group) were treated.

Reporting Groups
  Description
TAC (Docetaxel) docetaxel in combination with doxorubicin and cyclophosphamide
FAC (5-fluorouracil) 5-fluorouracil in combination with doxorubicin and cyclophosphamide

Participant Flow:   Overall Study
    TAC (Docetaxel)   FAC (5-fluorouracil)
STARTED   745   746 
COMPLETED   679   711 
NOT COMPLETED   66   35 
Adverse Event                45                8 
Death                2                2 
Lost to Follow-up                0                1 
Consent Withdrawn                17                17 
Breast Cancer Relapse                1                4 
Violation of Inclusion Criteria                1                3 



  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
TAC (Docetaxel) docetaxel in combination with doxorubicin and cyclophosphamide
FAC (5-fluorouracil) 5-fluorouracil in combination with doxorubicin and cyclophosphamide
Total Total of all reporting groups

Baseline Measures
   TAC (Docetaxel)   FAC (5-fluorouracil)   Total 
Overall Participants Analyzed 
[Units: Participants]
 745   746   1491 
Age 
[Units: Participants]
     
Between 18 and 65 years   697   705   1402 
>=65 years   48   41   89 
Gender 
[Units: Participants]
     
Female   745   746   1491 
Male   0   0   0 
Number of Positive Nodes 
[Units: Participants]
     
1-3 Positive Nodes   467   459   926 
4 or More Positive Nodes   278   287   565 


  Outcome Measures
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1.  Primary:   Number of Participants With Disease-Free Survival Events   [ Time Frame: up to 10 year follow-up ]

2.  Secondary:   Number of Participants With Overall Survival Events   [ Time Frame: up to 10 year follow-up ]

3.  Secondary:   Number of Participants With Second Primary Malignancies (Toxicity)   [ Time Frame: up to 10 year follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information