Trial · NCT00688740
Docetaxel in Node Positive Adjuvant Breast Cancer
NCT00688740, Phase 3, Completed, Sanofi; results first posted 2011-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel in Node Positive Adjuvant Breast Cancer. Trials, record NCT00688740. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00688740
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel in Node Positive Adjuvant Breast Cancer
- NCT number
- NCT00688740
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,491 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Breast Cancer
- Interventions
- Docetaxel, 5-fluorouracil, Doxorubicin, Cyclophosphamide
- First posted
- 2008-06-03
- Last updated
- 2011-02-16
- Results first posted
- 2011-02-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Disease-Free Survival Events | up to 10 year follow-up | 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. |
| Secondary | Number of Participants With Overall Survival Events | up to 10 year follow-up | Overall Survival - time from the date of randomization up to the date of death of any cause. |
| Secondary | Number of Participants With Second Primary Malignancies (Toxicity) | up to 10 year follow-up | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Disease-Free Survival Events | up to 10 year follow-up | 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) | Participants | NUMBER |
| SECONDARY | Number of Participants With Overall Survival Events | up to 10 year follow-up | Participants | NUMBER | |
| SECONDARY | Number of Participants With Second Primary Malignancies (Toxicity) | up to 10 year follow-up | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Disease-Free Survival Events | TAC (Docetaxel) | 287 | 0.579 to 0.650 | Participants | |
| Number of Participants With Disease-Free Survival Events | FAC (5-fluorouracil) | 333 | 0.513 to 0.586 | Participants | |
| Number of Participants With Overall Survival Events | TAC (Docetaxel) | 188 | 0.724 to 0.786 | Participants | |
| Number of Participants With Overall Survival Events | FAC (5-fluorouracil) | 241 | 0.651 to 0.719 | Participants | |
| Number of Participants With Second Primary Malignancies (Toxicity) | TAC (Docetaxel) | 67 | Participants | ||
| Number of Participants With Second Primary Malignancies (Toxicity) | FAC (5-fluorouracil) | 66 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAC (Docetaxel) | 745 | |
| Overall Study | STARTED | FAC (5-fluorouracil) | 746 | |
| Overall Study | COMPLETED | TAC (Docetaxel) | 679 | |
| Overall Study | COMPLETED | FAC (5-fluorouracil) | 711 | |
| Overall Study | NOT COMPLETED | TAC (Docetaxel) | 66 | |
| Overall Study | NOT COMPLETED | FAC (5-fluorouracil) | 35 |
Source ClinicalTrials.gov
Adverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Any skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | TAC (Docetaxel) | 734 | 744 | |
| other | Any skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | FAC (5-fluorouracil) | 718 | 736 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | TAC (Docetaxel) | 728 | 744 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | FAC (5-fluorouracil) | 715 | 736 | |
| other | Skin disorder | Skin and subcutaneous tissue disorders | TAC (Docetaxel) | 176 | 744 | |
| other | Skin disorder | Skin and subcutaneous tissue disorders | FAC (5-fluorouracil) | 105 | 736 | |
| other | Nail disorder | Skin and subcutaneous tissue disorders | TAC (Docetaxel) | 135 | 744 | |
| other | Nail disorder | Skin and subcutaneous tissue disorders | FAC (5-fluorouracil) | 103 | 736 | |
| other | Any gastrointestinal disorders | Gastrointestinal disorders | TAC (Docetaxel) | 713 | 744 | |
| other | Any gastrointestinal disorders | Gastrointestinal disorders | FAC (5-fluorouracil) | 709 | 736 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAC (Docetaxel) | ||
| Total, all-cause mortality | FAC (5-fluorouracil) | ||
| Total, other adverse events | TAC (Docetaxel) | 744 | 744 |
| Total, other adverse events | FAC (5-fluorouracil) | 734 | 736 |
| Total, serious adverse events | TAC (Docetaxel) | 267 | 744 |
| Total, serious adverse events | FAC (5-fluorouracil) | 67 | 736 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAC (Docetaxel) vs FAC (5-fluorouracil): Number of Participants With Disease-Free Survival Events | Trial comparisons |
| TAC (Docetaxel) vs FAC (5-fluorouracil): Number of Participants With Overall Survival Events | Trial comparisons |
| TAC (Docetaxel) vs FAC (5-fluorouracil): Number of Participants With Second Primary Malignancies (Toxicity) | Trial comparisons |
| TAC (Docetaxel) vs FAC (5-fluorouracil): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00688740
GET https://conductscience.org/api/trials/v1/NCT00688740/events?page=2