Trial · NCT00021255
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
NCT00021255, Phase 3, Completed, Sanofi; results first posted 2016-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer. Trials, record NCT00021255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00021255
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
- NCT number
- NCT00021255
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,222 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Breast Neoplasms
- Interventions
- Doxorubicin, Cyclophosphamide, Docetaxel, Herceptin, Carboplatin
- First posted
- 2003-01-27
- Last updated
- 2016-11-15
- Results first posted
- 2016-11-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Disease Free Survival at 5 Years | From randomization until relapse or death or up to 5 years | Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Disease Free Survival at 10 Years | From randomization until relapse or death or up to 10 years | Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival- Percentage of Participants Who Survived at 10 Years | From randomization until death or up to 10 years | Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method. |
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 | Percentage of Participants With Disease Free Survival at 5 Years | From randomization until relapse or death or up to 5 years | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Free Survival at 10 Years | From randomization until relapse or death or up to 10 years | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival- Percentage of Participants Who Survived at 10 Years | From randomization until death or up to 10 years | ITT population. | percentage of particpants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Disease Free Survival at 5 Years | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 75.5 | 95% Confidence Interval 72.8 to 78.2 | percentage of participants | |
| Percentage of Participants With Disease Free Survival at 5 Years | AC Followed by Docetaxel + Herceptin (AC→TH) | 83.2 | 95% Confidence Interval 80.9 to 85.4 | percentage of participants | |
| Percentage of Participants With Disease Free Survival at 5 Years | Docetaxel + Carboplatin + Herceptin (TCH) | 81.0 | 95% Confidence Interval 78.6 to 83.4 | percentage of participants | |
| Percentage of Participants With Disease Free Survival at 10 Years | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 67.2 | 95% Confidence Interval 64.2 to 70.2 | percentage of participants | |
| Percentage of Participants With Disease Free Survival at 10 Years | AC Followed by Docetaxel + Herceptin (AC→TH) | 73.4 | 95% Confidence Interval 70.6 to 76.2 | percentage of participants | |
| Percentage of Participants With Disease Free Survival at 10 Years | Docetaxel + Carboplatin + Herceptin (TCH) | 72.3 | 95% Confidence Interval 69.4 to 75.1 | percentage of participants | |
| Overall Survival- Percentage of Participants Who Survived at 10 Years | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 78.9 | 95% Confidence Interval 76.2 to 81.5 | percentage of particpants | |
| Overall Survival- Percentage of Participants Who Survived at 10 Years | AC Followed by Docetaxel + Herceptin (AC→TH) | 86.0 | 95% Confidence Interval 83.8 to 88.2 | percentage of particpants | |
| Overall Survival- Percentage of Participants Who Survived at 10 Years | Docetaxel + Carboplatin + Herceptin (TCH) | 83.4 | 95% Confidence Interval 81.0 to 85.8 | percentage of particpants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 1,073 | |
| Overall Study | STARTED | AC Followed by Docetaxel + Herceptin (AC→TH) | 1,074 | |
| Overall Study | STARTED | Docetaxel + Carboplatin + Herceptin (TCH) | 1,075 | |
| Overall Study | Treated | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 1,045 | |
| Overall Study | Treated | AC Followed by Docetaxel + Herceptin (AC→TH) | 1,072 | |
| Overall Study | Treated | Docetaxel + Carboplatin + Herceptin (TCH) | 1,057 | |
| Overall Study | Safety Population | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 1,018 | |
| Overall Study | Safety Population | AC Followed by Docetaxel + Herceptin (AC→TH) | 1,100 | |
| Overall Study | Safety Population | Docetaxel + Carboplatin + Herceptin (TCH) | 1,056 | |
| Overall Study | COMPLETED | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 952 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events615
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 | LYMPHEDEMA | Blood and lymphatic system disorders | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 81 | 1,018 | |
| other | LYMPHEDEMA | Blood and lymphatic system disorders | AC Followed by Docetaxel + Herceptin (AC→TH) | 94 | 1,100 | |
| other | LYMPHEDEMA | Blood and lymphatic system disorders | Docetaxel + Carboplatin + Herceptin (TCH) | 107 | 1,056 | |
| other | HYPERTENSION | Cardiac disorders | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 40 | 1,018 | |
| other | HYPERTENSION | Cardiac disorders | AC Followed by Docetaxel + Herceptin (AC→TH) | 72 | 1,100 | |
| other | HYPERTENSION | Cardiac disorders | Docetaxel + Carboplatin + Herceptin (TCH) | 78 | 1,056 | |
| other | LEFT HEART FAILURE | Cardiac disorders | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 30 | 1,018 | |
| other | LEFT HEART FAILURE | Cardiac disorders | AC Followed by Docetaxel + Herceptin (AC→TH) | 71 | 1,100 | |
| other | LEFT HEART FAILURE | Cardiac disorders | Docetaxel + Carboplatin + Herceptin (TCH) | 31 | 1,056 | |
| other | PALPITATION | Cardiac disorders | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 69 | 1,018 |
1 to 10 of 615Source ClinicalTrials.gov
See all 615 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | ||
| Total, all-cause mortality | AC Followed by Docetaxel + Herceptin (AC→TH) | ||
| Total, all-cause mortality | Docetaxel + Carboplatin + Herceptin (TCH) | ||
| Total, other adverse events | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 1,017 | 1,018 |
| Total, other adverse events | AC Followed by Docetaxel + Herceptin (AC→TH) | 1,100 | 1,100 |
| Total, other adverse events | Docetaxel + Carboplatin + Herceptin (TCH) | 1,052 | 1,056 |
| Total, serious adverse events | Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 218 | 1,018 |
| Total, serious adverse events | AC Followed by Docetaxel + Herceptin (AC→TH) | 298 | 1,100 |
| Total, serious adverse events | Docetaxel + Carboplatin + Herceptin (TCH) | 283 | 1,056 |
Source ClinicalTrials.gov
Papers8
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00021255
GET https://conductscience.org/api/trials/v1/NCT00021255/events?page=2