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
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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Consent Withdrawn                 17                 17  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  
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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: International Clinical Development Study Director
Organization: sanofi-aventis
e-mail: Contact-us@sanofi-aventis.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: ICD Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00688740     History of Changes
Other Study ID Numbers: EFC6041, XRP6976D-316, BCIRG001
Study First Received: May 29, 2008
Results First Received: January 25, 2011
Last Updated: February 14, 2011
Health Authority: Poland: Ministry of Health
Canada: Health Canada
Spain: Ministry of Health
United States: Food and Drug Administration