Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)
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| ClinicalTrials.gov Identifier: NCT00688740 |
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Recruitment Status :
Completed
First Posted : June 3, 2008
Results First Posted : February 14, 2011
Last Update Posted : February 16, 2011
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Sponsor:
Sanofi
Collaborator:
Cancer International Research Group (CIRG)
Information provided by:
Sanofi
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| 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 |
Participant Flow
| 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) |
|---|---|---|
 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| Consent Withdrawn | 17 | 17 |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 |
Baseline Characteristics
| Arm/Group Title | TAC (Docetaxel) | FAC (5-fluorouracil) | Total | |
|---|---|---|---|---|
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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 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 745 participants | 746 participants | 1491 participants | |
| Between 18 and 65 years |
697 93.6%
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705 94.5%
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1402 94.0%
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| >=65 years |
48 6.4%
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41 5.5%
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89 6.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 745 participants | 746 participants | 1491 participants | |
| Female |
745 100.0%
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746 100.0%
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1491 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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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 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
| EMail: | Contact-us@sanofi-aventis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ICD Study Director, Sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00688740 |
| 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 |