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

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
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Consent Withdrawn                17                17 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

  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