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Consent Withdrawn                 17                 17  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
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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     734/736  
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
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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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