Trial · NCT00003782
Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes
NCT00003782, Phase 3, Completed, NSABP Foundation Inc; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes. Trials, record NCT00003782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003782
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes
- NCT number
- NCT00003782
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,351 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Breast Cancer
- Interventions
- cyclophosphamide, docetaxel, doxorubicin
- First posted
- 2003-01-27
- Last updated
- 2024-03-21
- Results first posted
- 2012-10-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 8 years | |
| Primary | Disease Free Survival | time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event | |
| Secondary | Toxicities Among the 3 Regimens | 9 years | |
| Secondary | Quality of Life Among Breast Cancer Patients | baseline, 9 weeks, and 6, 12, 18, and 24 months | |
| Secondary | Amenorrhea in Premenopausal Women | baseline, 9 weeks, and 6, 12, 18, and 24 months |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 8 years | percentage of patients alive | NUMBER | |
| PRIMARY | Disease Free Survival | time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event | |||
| SECONDARY | Toxicities Among the 3 Regimens | 9 years | |||
| SECONDARY | Quality of Life Among Breast Cancer Patients | baseline, 9 weeks, and 6, 12, 18, and 24 months | |||
| SECONDARY | Amenorrhea in Premenopausal Women | baseline, 9 weeks, and 6, 12, 18, and 24 months |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel | 83 | percentage of patients alive | ||
| Overall Survival | Arm 2: Doxorubicin + Docetaxel | 79 | percentage of patients alive | ||
| Overall Survival | Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide | 79 | percentage of patients alive |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel | 1,783 | |
| Overall Study | STARTED | Arm 2: Doxorubicin + Docetaxel | 1,784 | |
| Overall Study | STARTED | Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide | 1,784 | |
| Overall Study | COMPLETED | Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel | 1,753 | |
| Overall Study | COMPLETED | Arm 2: Doxorubicin + Docetaxel | 1,753 | |
| Overall Study | COMPLETED | Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide | 1,758 | |
| Overall Study | NOT COMPLETED | Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel | 30 | |
| Overall Study | NOT COMPLETED | Arm 2: Doxorubicin + Docetaxel | 31 | |
| Overall Study | NOT COMPLETED | Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide | 26 |
Source ClinicalTrials.gov
Adverse events192
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Doxorubicin + Cyclophosphamide, Then Docetaxel | 126 | 1,748 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Doxorubicin + Docetaxel | 22 | 1,748 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Doxorubicin + Docetaxel + Cyclophosphamide | 33 | 1,745 | |
| other | Diarrhea | Gastrointestinal disorders | Doxorubicin + Cyclophosphamide, Then Docetaxel | 78 | 1,748 | |
| other | Diarrhea | Gastrointestinal disorders | Doxorubicin + Docetaxel | 66 | 1,748 | |
| other | Diarrhea | Gastrointestinal disorders | Doxorubicin + Docetaxel + Cyclophosphamide | 111 | 1,745 | |
| other | Fatigue | General disorders | Doxorubicin + Cyclophosphamide, Then Docetaxel | 212 | 1,748 | |
| other | Fatigue | General disorders | Doxorubicin + Docetaxel | 135 | 1,748 | |
| other | Fatigue | General disorders | Doxorubicin + Docetaxel + Cyclophosphamide | 167 | 1,745 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Doxorubicin + Cyclophosphamide, Then Docetaxel | 383 | 1,748 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxorubicin + Cyclophosphamide, Then Docetaxel | ||
| Total, all-cause mortality | Doxorubicin + Docetaxel | ||
| Total, all-cause mortality | Doxorubicin + Docetaxel + Cyclophosphamide | ||
| Total, other adverse events | Doxorubicin + Cyclophosphamide, Then Docetaxel | 845 | 1,748 |
| Total, other adverse events | Doxorubicin + Docetaxel | 561 | 1,748 |
| Total, other adverse events | Doxorubicin + Docetaxel + Cyclophosphamide | 641 | 1,745 |
| Total, serious adverse events | Doxorubicin + Cyclophosphamide, Then Docetaxel | 66 | 1,748 |
| Total, serious adverse events | Doxorubicin + Docetaxel | 43 | 1,748 |
| Total, serious adverse events | Doxorubicin + Docetaxel + Cyclophosphamide | 46 | 1,745 |
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 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/NCT00003782
GET https://conductscience.org/api/trials/v1/NCT00003782/events?page=2