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Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

This study has been completed.
Cancer International Research Group (CIRG)
Information provided by:
Sanofi Identifier:
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
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 
[units: participants]
 745   746   1491 
[units: participants]
Between 18 and 65 years   697   705   1402 
>=65 years   48   41   89 
[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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