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Consent Withdrawn	17	17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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Measure Type	Secondary
Measure Title	Number of Participants With Second Primary Malignancies (Toxicity)
Measure 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
Safety Issue	Yes

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

Measured Values

	TAC (Docetaxel)	FAC (5-fluorouracil)
Number of Participants Analyzed [units: participants]	745	746
Number of Participants With Second Primary Malignancies (Toxicity) [units: Participants]	67	66

No statistical analysis provided for Number of Participants With Second Primary Malignancies (Toxicity)

Serious Adverse Events

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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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