Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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Consent Withdrawn                 17                 17  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
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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.

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

Serious Adverse Events
    TAC (Docetaxel)     FAC (5-fluorouracil)  
Total, serious adverse events      
# participants affected / at risk     267/744 (35.89%)     67/736 (9.10%)  
Blood and lymphatic system disorders      
Neutropenia *    
# participants affected / at risk     2/744 (0.27%)     1/736 (0.14%)  
Anaemia *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Leukopenia *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Thrombocytopenia *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Thrombotic thrombocytopenic purpura *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Cardiac disorders      
Atrial flutter *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Cardiac arrest *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Myocardial ischaemia *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Arrhythmia *    
# participants affected / at risk     0/744 (0.00%)     2/736 (0.27%)  
Cardiac failure congestive *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Ear and labyrinth disorders      
Vertigo positional *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Gastrointestinal disorders      
Vomiting *    
# participants affected / at risk     11/744 (1.48%)     6/736 (0.82%)  
Nausea *    
# participants affected / at risk     8/744 (1.08%)     3/736 (0.41%)  
Diarrhoea *    
# participants affected / at risk     6/744 (0.81%)     1/736 (0.14%)  
Stomatitis *    
# participants affected / at risk     5/744 (0.67%)     0/736 (0.00%)  
Abdominal pain upper *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Caecitis *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Dyspepsia *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Oesophagitis *    
# participants affected / at risk     2/744 (0.27%)     1/736 (0.14%)  
Abdominal pain *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Constipation *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Duodenal ulcer, obstructive *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Gastritis *    
# participants affected / at risk     1/744 (0.13%)     1/736 (0.14%)  
Gastrointestinal inflammation *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Large intestine perforation *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Melaena *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Colitis ischaemic *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Duodenitis *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Gastrointestinal haemorrhage *    
# participants affected / at risk     0/744 (0.00%)     2/736 (0.27%)  
General disorders      
Fever in absence of infection *    
# participants affected / at risk     187/744 (25.13%)     24/736 (3.26%)  
Pyrexia *    
# participants affected / at risk     6/744 (0.81%)     2/736 (0.27%)  
Asthenia *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Chest pain *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Pain *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Injection site reaction *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Necrosis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Catheter related complication *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Catheter site inflammation *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Oedema peripheral *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Hepatobiliary disorders      
Cholecystitis acute *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Biliary colic *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Cholelithiasis *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Immune system disorders      
Hypersensitivity *    
# participants affected / at risk     4/744 (0.54%)     0/736 (0.00%)  
Infections and infestations      
Pharyngitis *    
# participants affected / at risk     7/744 (0.94%)     1/736 (0.14%)  
Pneumonia *    
# participants affected / at risk     4/744 (0.54%)     2/736 (0.27%)  
Sepsis *    
# participants affected / at risk     4/744 (0.54%)     2/736 (0.27%)  
Sinusitis *    
# participants affected / at risk     4/744 (0.54%)     0/736 (0.00%)  
Urinary tract infection *    
# participants affected / at risk     4/744 (0.54%)     3/736 (0.41%)  
Lung infection *    
# participants affected / at risk     3/744 (0.40%)     0/736 (0.00%)  
Abscess *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Catheter related infection *    
# participants affected / at risk     2/744 (0.27%)     3/736 (0.41%)  
Catheter site cellulitis *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Cellulitis *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Diverticulitis *    
# participants affected / at risk     2/744 (0.27%)     1/736 (0.14%)  
Lymphangitis *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Respiratory tract infection *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Tonsillitis *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Tooth abscess *    
# participants affected / at risk     2/744 (0.27%)     0/736 (0.00%)  
Upper respiratory tract infection *    
# participants affected / at risk     2/744 (0.27%)     1/736 (0.14%)  
Abscess oral *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Anal abscess *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Bronchitis *    
# participants affected / at risk     1/744 (0.13%)     1/736 (0.14%)  
Candidiasis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Clostridial infection *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Endocarditis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Escherichia infection *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Gastrointestinal infection *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Lobar pneumonia *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Localised infection *    
# participants affected / at risk     1/744 (0.13%)     1/736 (0.14%)  
Lower respiratory tract infection *    
# participants affected / at risk     1/744 (0.13%)     1/736 (0.14%)  
Neutropenic sepsis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Oral infection *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Pelvic inflammatory disease *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Postoperative wound infection *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Skin infection *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Staphylococcal skin infection *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Trichomoniasis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Vulvitis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Bacteraemia *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Breast infection *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Endometritis *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Oral candidiasis *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Peritoneal infection *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Pyelonephritis acute *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Vaginal infection *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Injury, poisoning and procedural complications      
Injury *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Lower limb fracture *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Subdural haematoma *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Investigations      
Haemoglobin *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Metabolism and nutrition disorders      
Dehydration *    
# participants affected / at risk     3/744 (0.40%)     2/736 (0.27%)  
Decreased appetite *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Diabetes mellitus *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Hyperglycaemia *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Hyponatraemia *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Endometrial cancer *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Nervous system disorders      
Syncope *    
# participants affected / at risk     2/744 (0.27%)     1/736 (0.14%)  
Essential tremor *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Headache *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Hypoaesthesia *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Loss of consciousness *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Cerebrovascular accident *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Psychiatric disorders      
Affective disorder *    
# participants affected / at risk     2/744 (0.27%)     1/736 (0.14%)  
Renal and urinary disorders      
Renal failure *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Renal failure acute *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Reproductive system and breast disorders      
Uterine haemorrhage *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Menometrorrhagia *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Respiratory, thoracic and mediastinal disorders      
Pulmonary embolism *    
# participants affected / at risk     5/744 (0.67%)     4/736 (0.54%)  
Chronic obstructive pulmonary disease *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Dyspnoea *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Lung disorder *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Oropharyngeal pain *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Pleural effusion *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Pneumothorax *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Pulmonary fibrosis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Haemothorax *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Skin and subcutaneous tissue disorders      
Psoriasis *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Vascular disorders      
Circulatory collapse *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Deep vein thrombosis *    
# participants affected / at risk     1/744 (0.13%)     4/736 (0.54%)  
Hypotension *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Orthostatic hypotension *    
# participants affected / at risk     1/744 (0.13%)     0/736 (0.00%)  
Haemorrhage *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Hypovolaemic shock *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
Lymphoedema *    
# participants affected / at risk     0/744 (0.00%)     1/736 (0.14%)  
* Events were collected by non-systematic assessment




  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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