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

History of Changes

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Consent Withdrawn	17	17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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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 ]

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2. Secondary:

Number of Participants With Overall Survival Events [ Time Frame: up to 10 year follow-up ]

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3. Secondary:

Number of Participants With Second Primary Malignancies (Toxicity) [ Time Frame: up to 10 year follow-up ]

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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

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

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.

Results Point of Contact:

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

Publications of Results:

Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13.

Publications automatically indexed to this study:

Mackey JR, Martin M, Pienkowski T, Rolski J, Guastalla JP, Sami A, Glaspy J, Juhos E, Wardley A, Fornander T, Hainsworth J, Coleman R, Modiano MR, Vinholes J, Pinter T, Rodríguez-Lescure A, Colwell B, Whitlock P, Provencher L, Laing K, Walde D, Price C, Hugh JC, Childs BH, Bassi K, Lindsay MA, Wilson V, Rupin M, Houé V, Vogel C; TRIO/BCIRG 001 investigators. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013 Jan;14(1):72-80. doi: 10.1016/S1470-2045(12)70525-9. Epub 2012 Dec 12.

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

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