Trial · NCT00312208
Docetaxel in Breast Cancer
NCT00312208, Phase 3, Completed, Sanofi; results first posted 2010-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel in Breast Cancer. Trials, record NCT00312208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00312208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel in Breast Cancer
- NCT number
- NCT00312208
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,299 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Breast Cancer
- Interventions
- docetaxel, doxorubicin, cyclophosphamide, Docetaxel,doxorubicin, cyclophosphamide
- First posted
- 2006-04-07
- Last updated
- 2013-12-30
- Results first posted
- 2010-02-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) | Median follow-up 65 months | The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. |
| Secondary | Death From Any Cause (Overall Survival) | Median follow-up of 65 months | The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) | Median follow-up 65 months | The primary efficacy analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median disease free survival time, median time-to-event was not reached in any group; therefore, number of participants with relapse was presented. | Participants | NUMBER |
| SECONDARY | Death From Any Cause (Overall Survival) | Median follow-up of 65 months | The analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median survival time, median time-to-event was not reached in any group; therefore, number of participants who died was presented. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 356 | Participants | ||
| Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 352 | Participants | ||
| Death From Any Cause (Overall Survival) | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 187 | 65.64 to 65.91 | Participants | |
| Death From Any Cause (Overall Survival) | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 202 | 65.48 to 65.84 | 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 | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 1,649 | |
| Overall Study | STARTED | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 1,649 | |
| Overall Study | COMPLETED | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 1,477 | |
| Overall Study | COMPLETED | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 1,526 | |
| Overall Study | NOT COMPLETED | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 172 | |
| Overall Study | NOT COMPLETED | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 123 |
Source ClinicalTrials.gov
Adverse events350
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 | Allergic reaction | General disorders | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 172 | 1,634 | |
| other | Allergic reaction | General disorders | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 190 | 1,635 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 1,601 | 1,634 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 1,587 | 1,635 | |
| other | Anemia | Blood and lymphatic system disorders | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 461 | 1,634 | |
| other | Anemia | Blood and lymphatic system disorders | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 658 | 1,635 | |
| other | Anorexia | Gastrointestinal disorders | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 370 | 1,634 | |
| other | Anorexia | Gastrointestinal disorders | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 376 | 1,635 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 602 | 1,634 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 382 | 1,635 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | ||
| Total, all-cause mortality | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | ||
| Total, other adverse events | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 1,634 | 1,634 |
| Total, other adverse events | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 1,629 | 1,635 |
| Total, serious adverse events | Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 331 | 1,634 |
| Total, serious adverse events | Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 520 | 1,635 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) vs Docetaxel + Doxorubicin and Cyclophosphamide (TAC): Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) | Trial comparisons |
| Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) vs Docetaxel + Doxorubicin and Cyclophosphamide (TAC): Death From Any Cause (Overall Survival) | Trial comparisons |
| Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) vs Docetaxel + Doxorubicin and Cyclophosphamide (TAC): 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/NCT00312208
GET https://conductscience.org/api/trials/v1/NCT00312208/events?page=2