Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

This study has been completed.
Sponsor:
Collaborator:
Cancer International Research Group (CIRG)
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
  Hide 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
  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Consent Withdrawn                17                17 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
  Hide 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.
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 
Overall Participants Analyzed 
[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
  Show All 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
  Hide Other Adverse Events

Time Frame from date of randomization until the completion of the 10-year follow-up period.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
TAC (Docetaxel) docetaxel in combination with doxorubicin and cyclophosphamide
FAC (5-fluorouracil) 5-fluorouracil in combination with doxorubicin and cyclophosphamide

Other Adverse Events
    TAC (Docetaxel)   FAC (5-fluorouracil)
Total, other (not including serious) adverse events     
# participants affected / at risk   744/744 (100.00%)   734/736 (99.73%) 
Cardiac disorders     
Any cardiac disorders     
# participants affected / at risk   77/744 (10.35%)   51/736 (6.93%) 
Arrhythmia     
# participants affected / at risk   46/744 (6.18%)   35/736 (4.76%) 
Eye disorders     
Any eye disorders     
# participants affected / at risk   194/744 (26.08%)   167/736 (22.69%) 
Lacrimation increased     
# participants affected / at risk   87/744 (11.69%)   52/736 (7.07%) 
Gastrointestinal disorders     
Any gastrointestinal disorders     
# participants affected / at risk   713/744 (95.83%)   709/736 (96.33%) 
Nausea     
# participants affected / at risk   599/744 (80.51%)   647/736 (87.91%) 
Stomatitis     
# participants affected / at risk   508/744 (68.28%)   374/736 (50.82%) 
Vomiting     
# participants affected / at risk   327/744 (43.95%)   436/736 (59.24%) 
Constipation     
# participants affected / at risk   271/744 (36.42%)   255/736 (34.65%) 
Diarrhoea     
# participants affected / at risk   259/744 (34.81%)   205/736 (27.85%) 
Dyspepsia     
# participants affected / at risk   178/744 (23.92%)   132/736 (17.93%) 
Haemorrhoids     
# participants affected / at risk   57/744 (7.66%)   35/736 (4.76%) 
Abdominal pain upper     
# participants affected / at risk   44/744 (5.91%)   22/736 (2.99%) 
Dry mouth     
# participants affected / at risk   36/744 (4.84%)   43/736 (5.84%) 
General disorders     
Any general disorders and administration site conditions     
# participants affected / at risk   673/744 (90.46%)   610/736 (82.88%) 
Asthenia     
# participants affected / at risk   592/744 (79.57%)   513/736 (69.70%) 
Pain     
# participants affected / at risk   312/744 (41.94%)   264/736 (35.87%) 
Oedema peripheral     
# participants affected / at risk   250/744 (33.60%)   91/736 (12.36%) 
Pyrexia     
# participants affected / at risk   152/744 (20.43%)   87/736 (11.82%) 
Injection site reaction     
# participants affected / at risk   99/744 (13.31%)   88/736 (11.96%) 
Chills     
# participants affected / at risk   53/744 (7.12%)   29/736 (3.94%) 
Fever in absence of infection     
# participants affected / at risk   112/744 (15.05%)   40/736 (5.43%) 
Immune system disorders     
Any immune system disorders     
# participants affected / at risk   93/744 (12.50%)   24/736 (3.26%) 
Hypersensitivity     
# participants affected / at risk   82/744 (11.02%)   21/736 (2.85%) 
Infections and infestations     
Any infections and infestations     
# participants affected / at risk   295/744 (39.65%)   293/736 (39.81%) 
Nasopharyngitis     
# participants affected / at risk   45/744 (6.05%)   62/736 (8.42%) 
Upper respiratory tract infection     
# participants affected / at risk   35/744 (4.70%)   53/736 (7.20%) 
Investigations     
Any investigations     
# participants affected / at risk   171/744 (22.98%)   144/736 (19.57%) 
Weight increased     
# participants affected / at risk   131/744 (17.61%)   108/736 (14.67%) 
Metabolism and nutrition disorders     
Any metabolism and nutrition disorders     
# participants affected / at risk   185/744 (24.87%)   140/736 (19.02%) 
Decreased appetite     
# participants affected / at risk   161/744 (21.64%)   130/736 (17.66%) 
Musculoskeletal and connective tissue disorders     
Any musculoskeletal and connective tissue disorders     
# participants affected / at risk   290/744 (38.98%)   152/736 (20.65%) 
Myalgia     
# participants affected / at risk   199/744 (26.75%)   73/736 (9.92%) 
Arthralgia     
# participants affected / at risk   144/744 (19.35%)   67/736 (9.10%) 
Nervous system disorders     
Any nervous system disorders     
# participants affected / at risk   427/744 (57.39%)   318/736 (43.21%) 
Dysgeusia     
# participants affected / at risk   206/744 (27.69%)   112/736 (15.22%) 
Peripheral sensory neuropathy     
# participants affected / at risk   185/744 (24.87%)   70/736 (9.51%) 
Headache     
# participants affected / at risk   153/744 (20.56%)   169/736 (22.96%) 
Dizziness     
# participants affected / at risk   63/744 (8.47%)   50/736 (6.79%) 
Psychiatric disorders     
Any psychiatric disorders     
# participants affected / at risk   214/744 (28.76%)   170/736 (23.10%) 
Insomnia     
# participants affected / at risk   122/744 (16.40%)   83/736 (11.28%) 
Affective disorder     
# participants affected / at risk   82/744 (11.02%)   76/736 (10.33%) 
Reproductive system and breast disorders     
Any reproductive system and breast disorders     
# participants affected / at risk   307/744 (41.26%)   268/736 (36.41%) 
Amenorrhoea     
# participants affected / at risk   212/744 (28.49%)   136/736 (18.48%) 
Menstruation irregular     
# participants affected / at risk   211/744 (28.36%)   165/736 (22.42%) 
Respiratory, thoracic and mediastinal disorders     
Any respiratory, thoracic and mediastinal disorders     
# participants affected / at risk   280/744 (37.63%)   196/736 (26.63%) 
Lung disorder     
# participants affected / at risk   117/744 (15.73%)   64/736 (8.70%) 
Cough     
# participants affected / at risk   100/744 (13.44%)   72/736 (9.78%) 
Oropharyngeal pain     
# participants affected / at risk   60/744 (8.06%)   53/736 (7.20%) 
Rhinorrhoea     
# participants affected / at risk   39/744 (5.24%)   27/736 (3.67%) 
Skin and subcutaneous tissue disorders     
Any skin and subcutaneous tissue disorders     
# participants affected / at risk   734/744 (98.66%)   718/736 (97.55%) 
Alopecia     
# participants affected / at risk   728/744 (97.85%)   715/736 (97.15%) 
Skin disorder     
# participants affected / at risk   176/744 (23.66%)   105/736 (14.27%) 
Nail disorder     
# participants affected / at risk   135/744 (18.15%)   103/736 (13.99%) 
Vascular disorders     
Any vascular disorders     
# participants affected / at risk   271/744 (36.42%)   194/736 (26.36%) 
Hot flush     
# participants affected / at risk   184/744 (24.73%)   147/736 (19.97%) 
Flushing     
# participants affected / at risk   49/744 (6.59%)   26/736 (3.53%) 
* Events were collected by non-systematic assessment



  Limitations and Caveats
  Hide 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
No text entered.


  More Information