Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688740
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : February 14, 2011
Last Update Posted : February 16, 2011
Cancer International Research Group (CIRG)
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Docetaxel
Drug: 5-fluorouracil
Drug: Doxorubicin
Drug: Cyclophosphamide

  Participant Flow

  Baseline Characteristics

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 Analyzed 
[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

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

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