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Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

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ClinicalTrials.gov Identifier: NCT00688740
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : February 14, 2011
Last Update Posted : February 16, 2011
Sponsor:
Collaborator:
Cancer International Research Group (CIRG)
Information provided by:
Sanofi

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
Enrollment 1491
Recruitment Details 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 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.
Arm/Group Title TAC (Docetaxel) FAC (5-fluorouracil)
Hide Arm/Group Description docetaxel in combination with doxorubicin and cyclophosphamide 5-fluorouracil in combination with doxorubicin and cyclophosphamide
Period Title: Overall Study
Started 745 746
Completed 679 711
Not Completed 66 35
Reason Not Completed
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Consent Withdrawn             17             17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
Arm/Group Title TAC (Docetaxel) FAC (5-fluorouracil) Total
Hide Arm/Group Description docetaxel in combination with doxorubicin and cyclophosphamide 5-fluorouracil in combination with doxorubicin and cyclophosphamide Total of all reporting groups
Overall Number of Baseline Participants 745 746 1491
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 745 participants 746 participants 1491 participants
Between 18 and 65 years
697
  93.6%
705
  94.5%
1402
  94.0%
>=65 years
48
   6.4%
41
   5.5%
89
   6.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 745 participants 746 participants 1491 participants
Female
745
 100.0%
746
 100.0%
1491
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Number of Positive Nodes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 745 participants 746 participants 1491 participants
1-3 Positive Nodes 467 459 926
4 or More Positive Nodes 278 287 565
1.Primary Outcome
Title Number of Participants With Disease-Free Survival Events
Hide Description Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.
Time Frame up to 10 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was originally designed to have 90% power to detect a 26% risk reduction of relapsing for TAC compared to FAC (hazard ratio=0.74)
Arm/Group Title TAC (Docetaxel) FAC (5-fluorouracil)
Hide Arm/Group Description:
docetaxel in combination with doxorubicin and cyclophosphamide
5-fluorouracil in combination with doxorubicin and cyclophosphamide
Overall Number of Participants Analyzed 745 746
Measure Type: Number
Unit of Measure: Participants
287 333
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAC (Docetaxel), FAC (5-fluorouracil)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.795
Confidence Interval (2-Sided) 95%
0.679 to 0.932
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Overall Survival Events
Hide Description Overall Survival - time from the date of randomization up to the date of death of any cause.
Time Frame up to 10 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAC (Docetaxel) FAC (5-fluorouracil)
Hide Arm/Group Description:
docetaxel in combination with doxorubicin and cyclophosphamide
5-fluorouracil in combination with doxorubicin and cyclophosphamide
Overall Number of Participants Analyzed 745 746
Measure Type: Number
Unit of Measure: Participants
188 241
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAC (Docetaxel), FAC (5-fluorouracil)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.742
Confidence Interval (2-Sided) 95%
0.613 to 0.898
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Second Primary Malignancies (Toxicity)
Hide Description Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.
Time Frame up to 10 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAC (Docetaxel) FAC (5-fluorouracil)
Hide Arm/Group Description:
docetaxel in combination with doxorubicin and cyclophosphamide
5-fluorouracil in combination with doxorubicin and cyclophosphamide
Overall Number of Participants Analyzed 745 746
Measure Type: Number
Unit of Measure: Participants
67 66
Time Frame from date of randomization until the completion of the 10-year follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAC (Docetaxel) FAC (5-fluorouracil)
Hide Arm/Group Description docetaxel in combination with doxorubicin and cyclophosphamide 5-fluorouracil in combination with doxorubicin and cyclophosphamide
All-Cause Mortality
TAC (Docetaxel) FAC (5-fluorouracil)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAC (Docetaxel) FAC (5-fluorouracil)
Affected / at Risk (%) Affected / at Risk (%)
Total   267/744 (35.89%)   67/736 (9.10%) 
Blood and lymphatic system disorders     
Neutropenia *  2/744 (0.27%)  1/736 (0.14%) 
Anaemia *  1/744 (0.13%)  0/736 (0.00%) 
Leukopenia *  1/744 (0.13%)  0/736 (0.00%) 
Thrombocytopenia *  1/744 (0.13%)  0/736 (0.00%) 
Thrombotic thrombocytopenic purpura *  1/744 (0.13%)  0/736 (0.00%) 
Cardiac disorders     
Atrial flutter *  1/744 (0.13%)  0/736 (0.00%) 
Cardiac arrest *  1/744 (0.13%)  0/736 (0.00%) 
Myocardial ischaemia *  1/744 (0.13%)  0/736 (0.00%) 
Arrhythmia *  0/744 (0.00%)  2/736 (0.27%) 
Cardiac failure congestive *  0/744 (0.00%)  1/736 (0.14%) 
Ear and labyrinth disorders     
Vertigo positional *  0/744 (0.00%)  1/736 (0.14%) 
Gastrointestinal disorders     
Vomiting *  11/744 (1.48%)  6/736 (0.82%) 
Nausea *  8/744 (1.08%)  3/736 (0.41%) 
Diarrhoea *  6/744 (0.81%)  1/736 (0.14%) 
Stomatitis *  5/744 (0.67%)  0/736 (0.00%) 
Abdominal pain upper *  2/744 (0.27%)  0/736 (0.00%) 
Caecitis *  2/744 (0.27%)  0/736 (0.00%) 
Dyspepsia *  2/744 (0.27%)  0/736 (0.00%) 
Oesophagitis *  2/744 (0.27%)  1/736 (0.14%) 
Abdominal pain *  1/744 (0.13%)  0/736 (0.00%) 
Constipation *  1/744 (0.13%)  0/736 (0.00%) 
Duodenal ulcer, obstructive *  1/744 (0.13%)  0/736 (0.00%) 
Gastritis *  1/744 (0.13%)  1/736 (0.14%) 
Gastrointestinal inflammation *  1/744 (0.13%)  0/736 (0.00%) 
Large intestine perforation *  1/744 (0.13%)  0/736 (0.00%) 
Melaena *  1/744 (0.13%)  0/736 (0.00%) 
Colitis ischaemic *  0/744 (0.00%)  1/736 (0.14%) 
Duodenitis *  0/744 (0.00%)  1/736 (0.14%) 
Gastrointestinal haemorrhage *  0/744 (0.00%)  2/736 (0.27%) 
General disorders     
Fever in absence of infection *  187/744 (25.13%)  24/736 (3.26%) 
Pyrexia *  6/744 (0.81%)  2/736 (0.27%) 
Asthenia *  2/744 (0.27%)  0/736 (0.00%) 
Chest pain *  2/744 (0.27%)  0/736 (0.00%) 
Pain *  2/744 (0.27%)  0/736 (0.00%) 
Injection site reaction *  1/744 (0.13%)  0/736 (0.00%) 
Necrosis *  1/744 (0.13%)  0/736 (0.00%) 
Catheter related complication *  0/744 (0.00%)  1/736 (0.14%) 
Catheter site inflammation *  0/744 (0.00%)  1/736 (0.14%) 
Oedema peripheral *  0/744 (0.00%)  1/736 (0.14%) 
Hepatobiliary disorders     
Cholecystitis acute *  2/744 (0.27%)  0/736 (0.00%) 
Biliary colic *  1/744 (0.13%)  0/736 (0.00%) 
Cholelithiasis *  0/744 (0.00%)  1/736 (0.14%) 
Immune system disorders     
Hypersensitivity *  4/744 (0.54%)  0/736 (0.00%) 
Infections and infestations     
Pharyngitis *  7/744 (0.94%)  1/736 (0.14%) 
Pneumonia *  4/744 (0.54%)  2/736 (0.27%) 
Sepsis *  4/744 (0.54%)  2/736 (0.27%) 
Sinusitis *  4/744 (0.54%)  0/736 (0.00%) 
Urinary tract infection *  4/744 (0.54%)  3/736 (0.41%) 
Lung infection *  3/744 (0.40%)  0/736 (0.00%) 
Abscess *  2/744 (0.27%)  0/736 (0.00%) 
Catheter related infection *  2/744 (0.27%)  3/736 (0.41%) 
Catheter site cellulitis *  2/744 (0.27%)  0/736 (0.00%) 
Cellulitis *  2/744 (0.27%)  0/736 (0.00%) 
Diverticulitis *  2/744 (0.27%)  1/736 (0.14%) 
Lymphangitis *  2/744 (0.27%)  0/736 (0.00%) 
Respiratory tract infection *  2/744 (0.27%)  0/736 (0.00%) 
Tonsillitis *  2/744 (0.27%)  0/736 (0.00%) 
Tooth abscess *  2/744 (0.27%)  0/736 (0.00%) 
Upper respiratory tract infection *  2/744 (0.27%)  1/736 (0.14%) 
Abscess oral *  1/744 (0.13%)  0/736 (0.00%) 
Anal abscess *  1/744 (0.13%)  0/736 (0.00%) 
Bronchitis *  1/744 (0.13%)  1/736 (0.14%) 
Candidiasis *  1/744 (0.13%)  0/736 (0.00%) 
Clostridial infection *  1/744 (0.13%)  0/736 (0.00%) 
Endocarditis *  1/744 (0.13%)  0/736 (0.00%) 
Escherichia infection *  1/744 (0.13%)  0/736 (0.00%) 
Gastrointestinal infection *  1/744 (0.13%)  0/736 (0.00%) 
Lobar pneumonia *  1/744 (0.13%)  0/736 (0.00%) 
Localised infection *  1/744 (0.13%)  1/736 (0.14%) 
Lower respiratory tract infection *  1/744 (0.13%)  1/736 (0.14%) 
Neutropenic sepsis *  1/744 (0.13%)  0/736 (0.00%) 
Oral infection *  1/744 (0.13%)  0/736 (0.00%) 
Pelvic inflammatory disease *  1/744 (0.13%)  0/736 (0.00%) 
Postoperative wound infection *  1/744 (0.13%)  0/736 (0.00%) 
Skin infection *  1/744 (0.13%)  0/736 (0.00%) 
Staphylococcal skin infection *  1/744 (0.13%)  0/736 (0.00%) 
Trichomoniasis *  1/744 (0.13%)  0/736 (0.00%) 
Vulvitis *  1/744 (0.13%)  0/736 (0.00%) 
Bacteraemia *  0/744 (0.00%)  1/736 (0.14%) 
Breast infection *  0/744 (0.00%)  1/736 (0.14%) 
Endometritis *  0/744 (0.00%)  1/736 (0.14%) 
Oral candidiasis *  0/744 (0.00%)  1/736 (0.14%) 
Peritoneal infection *  0/744 (0.00%)  1/736 (0.14%) 
Pyelonephritis acute *  0/744 (0.00%)  1/736 (0.14%) 
Vaginal infection *  0/744 (0.00%)  1/736 (0.14%) 
Injury, poisoning and procedural complications     
Injury *  1/744 (0.13%)  0/736 (0.00%) 
Lower limb fracture *  1/744 (0.13%)  0/736 (0.00%) 
Subdural haematoma *  0/744 (0.00%)  1/736 (0.14%) 
Investigations     
Haemoglobin *  0/744 (0.00%)  1/736 (0.14%) 
Metabolism and nutrition disorders     
Dehydration *  3/744 (0.40%)  2/736 (0.27%) 
Decreased appetite *  1/744 (0.13%)  0/736 (0.00%) 
Diabetes mellitus *  1/744 (0.13%)  0/736 (0.00%) 
Hyperglycaemia *  1/744 (0.13%)  0/736 (0.00%) 
Hyponatraemia *  0/744 (0.00%)  1/736 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Endometrial cancer *  0/744 (0.00%)  1/736 (0.14%) 
Nervous system disorders     
Syncope *  2/744 (0.27%)  1/736 (0.14%) 
Essential tremor *  1/744 (0.13%)  0/736 (0.00%) 
Headache *  1/744 (0.13%)  0/736 (0.00%) 
Hypoaesthesia *  1/744 (0.13%)  0/736 (0.00%) 
Loss of consciousness *  1/744 (0.13%)  0/736 (0.00%) 
Cerebrovascular accident *  0/744 (0.00%)  1/736 (0.14%) 
Psychiatric disorders     
Affective disorder *  2/744 (0.27%)  1/736 (0.14%) 
Renal and urinary disorders     
Renal failure *  1/744 (0.13%)  0/736 (0.00%) 
Renal failure acute *  1/744 (0.13%)  0/736 (0.00%) 
Reproductive system and breast disorders     
Uterine haemorrhage *  1/744 (0.13%)  0/736 (0.00%) 
Menometrorrhagia *  0/744 (0.00%)  1/736 (0.14%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism *  5/744 (0.67%)  4/736 (0.54%) 
Chronic obstructive pulmonary disease *  1/744 (0.13%)  0/736 (0.00%) 
Dyspnoea *  1/744 (0.13%)  0/736 (0.00%) 
Lung disorder *  1/744 (0.13%)  0/736 (0.00%) 
Oropharyngeal pain *  1/744 (0.13%)  0/736 (0.00%) 
Pleural effusion *  1/744 (0.13%)  0/736 (0.00%) 
Pneumothorax *  1/744 (0.13%)  0/736 (0.00%) 
Pulmonary fibrosis *  1/744 (0.13%)  0/736 (0.00%) 
Haemothorax *  0/744 (0.00%)  1/736 (0.14%) 
Skin and subcutaneous tissue disorders     
Psoriasis *  1/744 (0.13%)  0/736 (0.00%) 
Vascular disorders     
Circulatory collapse *  1/744 (0.13%)  0/736 (0.00%) 
Deep vein thrombosis *  1/744 (0.13%)  4/736 (0.54%) 
Hypotension *  1/744 (0.13%)  0/736 (0.00%) 
Orthostatic hypotension *  1/744 (0.13%)  0/736 (0.00%) 
Haemorrhage *  0/744 (0.00%)  1/736 (0.14%) 
Hypovolaemic shock *  0/744 (0.00%)  1/736 (0.14%) 
Lymphoedema *  0/744 (0.00%)  1/736 (0.14%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAC (Docetaxel) FAC (5-fluorouracil)
Affected / at Risk (%) Affected / at Risk (%)
Total   744/744 (100.00%)   734/736 (99.73%) 
Cardiac disorders     
Any cardiac disorders *  77/744 (10.35%)  51/736 (6.93%) 
Arrhythmia *  46/744 (6.18%)  35/736 (4.76%) 
Eye disorders     
Any eye disorders *  194/744 (26.08%)  167/736 (22.69%) 
Lacrimation increased *  87/744 (11.69%)  52/736 (7.07%) 
Gastrointestinal disorders     
Any gastrointestinal disorders *  713/744 (95.83%)  709/736 (96.33%) 
Nausea *  599/744 (80.51%)  647/736 (87.91%) 
Stomatitis *  508/744 (68.28%)  374/736 (50.82%) 
Vomiting *  327/744 (43.95%)  436/736 (59.24%) 
Constipation *  271/744 (36.42%)  255/736 (34.65%) 
Diarrhoea *  259/744 (34.81%)  205/736 (27.85%) 
Dyspepsia *  178/744 (23.92%)  132/736 (17.93%) 
Haemorrhoids *  57/744 (7.66%)  35/736 (4.76%) 
Abdominal pain upper *  44/744 (5.91%)  22/736 (2.99%) 
Dry mouth *  36/744 (4.84%)  43/736 (5.84%) 
General disorders     
Any general disorders and administration site conditions *  673/744 (90.46%)  610/736 (82.88%) 
Asthenia *  592/744 (79.57%)  513/736 (69.70%) 
Pain *  312/744 (41.94%)  264/736 (35.87%) 
Oedema peripheral *  250/744 (33.60%)  91/736 (12.36%) 
Pyrexia *  152/744 (20.43%)  87/736 (11.82%) 
Injection site reaction *  99/744 (13.31%)  88/736 (11.96%) 
Chills *  53/744 (7.12%)  29/736 (3.94%) 
Fever in absence of infection *  112/744 (15.05%)  40/736 (5.43%) 
Immune system disorders     
Any immune system disorders *  93/744 (12.50%)  24/736 (3.26%) 
Hypersensitivity *  82/744 (11.02%)  21/736 (2.85%) 
Infections and infestations     
Any infections and infestations *  295/744 (39.65%)  293/736 (39.81%) 
Nasopharyngitis *  45/744 (6.05%)  62/736 (8.42%) 
Upper respiratory tract infection *  35/744 (4.70%)  53/736 (7.20%) 
Investigations     
Any investigations *  171/744 (22.98%)  144/736 (19.57%) 
Weight increased *  131/744 (17.61%)  108/736 (14.67%) 
Metabolism and nutrition disorders     
Any metabolism and nutrition disorders *  185/744 (24.87%)  140/736 (19.02%) 
Decreased appetite *  161/744 (21.64%)  130/736 (17.66%) 
Musculoskeletal and connective tissue disorders     
Any musculoskeletal and connective tissue disorders *  290/744 (38.98%)  152/736 (20.65%) 
Myalgia *  199/744 (26.75%)  73/736 (9.92%) 
Arthralgia *  144/744 (19.35%)  67/736 (9.10%) 
Nervous system disorders     
Any nervous system disorders *  427/744 (57.39%)  318/736 (43.21%) 
Dysgeusia *  206/744 (27.69%)  112/736 (15.22%) 
Peripheral sensory neuropathy *  185/744 (24.87%)  70/736 (9.51%) 
Headache *  153/744 (20.56%)  169/736 (22.96%) 
Dizziness *  63/744 (8.47%)  50/736 (6.79%) 
Psychiatric disorders     
Any psychiatric disorders *  214/744 (28.76%)  170/736 (23.10%) 
Insomnia *  122/744 (16.40%)  83/736 (11.28%) 
Affective disorder *  82/744 (11.02%)  76/736 (10.33%) 
Reproductive system and breast disorders     
Any reproductive system and breast disorders *  307/744 (41.26%)  268/736 (36.41%) 
Amenorrhoea *  212/744 (28.49%)  136/736 (18.48%) 
Menstruation irregular *  211/744 (28.36%)  165/736 (22.42%) 
Respiratory, thoracic and mediastinal disorders     
Any respiratory, thoracic and mediastinal disorders *  280/744 (37.63%)  196/736 (26.63%) 
Lung disorder *  117/744 (15.73%)  64/736 (8.70%) 
Cough *  100/744 (13.44%)  72/736 (9.78%) 
Oropharyngeal pain *  60/744 (8.06%)  53/736 (7.20%) 
Rhinorrhoea *  39/744 (5.24%)  27/736 (3.67%) 
Skin and subcutaneous tissue disorders     
Any skin and subcutaneous tissue disorders *  734/744 (98.66%)  718/736 (97.55%) 
Alopecia *  728/744 (97.85%)  715/736 (97.15%) 
Skin disorder *  176/744 (23.66%)  105/736 (14.27%) 
Nail disorder *  135/744 (18.15%)  103/736 (13.99%) 
Vascular disorders     
Any vascular disorders *  271/744 (36.42%)  194/736 (26.36%) 
Hot flush *  184/744 (24.73%)  147/736 (19.97%) 
Flushing *  49/744 (6.59%)  26/736 (3.53%) 
*
Indicates events were collected by non-systematic assessment
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.
No publication of the study will be made without approval of the advisory board of the Breast Cancer International Research Group and Rhone- Poulenc Rorer.
Results Point of Contact
Name/Title: International Clinical Development Study Director
Organization: sanofi-aventis
Responsible Party: ICD Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00688740     History of Changes
Other Study ID Numbers: EFC6041
XRP6976D-316
BCIRG001
First Submitted: May 29, 2008
First Posted: June 3, 2008
Results First Submitted: January 25, 2011
Results First Posted: February 14, 2011
Last Update Posted: February 16, 2011