Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

This study has been completed.
Sponsor:
Collaborator:
Cancer International Research Group
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


  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.
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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  
Number of Participants  
[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
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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