Trial · NCT00041119
Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer
NCT00041119, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer. Trials, record NCT00041119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00041119
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer
- NCT number
- NCT00041119
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,871 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Breast Cancer
- Interventions
- AC regimen, cyclophosphamide, doxorubicin hydrochloride, paclitaxel
- First posted
- 2003-01-27
- Last updated
- 2017-05-18
- Results first posted
- 2017-05-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse Free Survival (RFS) 4 vs. 6 Cycles | from baseline up to 4 years | To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together. |
| Primary | Duration of Disease Free Survival (RFS) | from baseline up to 6.4 years | To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. Objective progression is defined as the appearance of local (chest wall, axillary, supraclavicular nodes) or distant metastases. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis. |
| Secondary | Overall Survival (OS) | from baseline up to 5 years | To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for overall survival. OS will be measured from study entry until death due to any cause. Survivors will be censored at the date of last follow-up.. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis. |
| Secondary | Adverse Events | from baseline up to 6 weeks post-treatment | To compare toxicities of short course CA and paclitaxel with long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer. The percentage of patients that received a grade 3 or higher hematologic event will be reported here. We will be combining arm I with arm III, as well as arm II with arm IV. For a complete list of adverse events, please refer to the adverse events section. |
| Secondary | Time to Distant Metastases | from baseline up to 15 years | Local control and distant metastasis will be calculated as the cumulative incidence of first local relapse and first distant metastasis, respectively. |
| Secondary | Local Control | from baseline up to 15 years | Local control will be calculated as the cumulative incidence of first local relapse. |
| Secondary | Overall Survival (OS) for 4 vs. 6 Cycles | from baseline up to 4 years | To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for overall survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relapse Free Survival (RFS) 4 vs. 6 Cycles | from baseline up to 4 years | All patients that were eligible and received treatment were analyzed. 700 patients were not included due to the timing that the analysis was performed. | years | MEDIAN |
| PRIMARY | Duration of Disease Free Survival (RFS) | from baseline up to 6.4 years | All eligible patients were treated and analyzed. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | from baseline up to 5 years | All patients that were eligible and treated for the study were evaluated. | percentage of participants at 5 years | NUMBER |
| SECONDARY | Adverse Events | from baseline up to 6 weeks post-treatment | 3754 patients were considered evaluable for toxicity that occurred during treatment. | percentage of patients | NUMBER |
| SECONDARY | Time to Distant Metastases | from baseline up to 15 years | All patients that were eligible and received treatment were analyzed. | years | MEDIAN |
| SECONDARY | Local Control | from baseline up to 15 years | All patients that were eligible and received treatment were analyzed. | years | MEDIAN |
| SECONDARY | Overall Survival (OS) for 4 vs. 6 Cycles | from baseline up to 4 years | All patients that were eligible and received treatment were analyzed. | percentage of patients at 4 years | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relapse Free Survival (RFS) 4 vs. 6 Cycles | 4 Cycles (Arm I and Arm III Combined) | NA | Full Range NA to NA | years | |
| Relapse Free Survival (RFS) 4 vs. 6 Cycles | 6 Cycles (Arm II and Arm IV Combined) | NA | Full Range NA to NA | years | |
| Duration of Disease Free Survival (RFS) | Arm V (Arm I and Arm II Combined) | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Disease Free Survival (RFS) | Arm VI (Arm III and Arm IV) Combined | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Cyclophosphamide and Doxorubicin Hydrochloride | 95 | percentage of participants at 5 years | ||
| Overall Survival (OS) | Paclitaxel | 94 | percentage of participants at 5 years | ||
| Adverse Events | 6 Cycles | 38 | percentage of patients | ||
| Adverse Events | 4 Cycles | 29 | percentage of patients | ||
| Time to Distant Metastases | Cyclophosphamide and Doxorubicin Hydrochloride | NA | Full Range NA to NA | years | |
| Time to Distant Metastases | Paclitaxel | NA | Full Range NA to NA | years |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (CA for 4 Courses) | 1,142 | |
| Overall Study | STARTED | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 789 | |
| Overall Study | STARTED | Arm III (Paclitaxel for 4 Courses) | 1,151 | |
| Overall Study | STARTED | Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007]) | 789 | |
| Overall Study | COMPLETED | Arm I (CA for 4 Courses) | 1,142 | |
| Overall Study | COMPLETED | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 789 | |
| Overall Study | COMPLETED | Arm III (Paclitaxel for 4 Courses) | 1,151 | |
| Overall Study | COMPLETED | Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007]) | 789 | |
| Overall Study | NOT COMPLETED | Arm I (CA for 4 Courses) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,400
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 | Anemia | Blood and lymphatic system disorders | Arm I (CA for 4 Courses) | 0 | 1,110 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 1 | 765 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Arm III (Paclitaxel for 4 Courses) | 1 | 1,118 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007]) | 0 | 762 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (CA for 4 Courses) | 44 | 1,110 | 52 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 33 | 765 | 41 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm III (Paclitaxel for 4 Courses) | 3 | 1,118 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007]) | 1 | 762 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (CA for 4 Courses) | 698 | 1,110 | 1,742 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 519 | 765 | 1,789 |
1 to 10 of 1,400Source ClinicalTrials.gov
See all 1,400 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (CA for 4 Courses) | ||
| Total, all-cause mortality | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | ||
| Total, all-cause mortality | Arm III (Paclitaxel for 4 Courses) | ||
| Total, all-cause mortality | Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007]) | ||
| Total, other adverse events | Arm I (CA for 4 Courses) | 940 | 1,110 |
| Total, other adverse events | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 687 | 765 |
| Total, other adverse events | Arm III (Paclitaxel for 4 Courses) | 975 | 1,118 |
| Total, other adverse events | Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007]) | 668 | 762 |
| Total, serious adverse events | Arm I (CA for 4 Courses) | 113 | 1,142 |
| Total, serious adverse events | Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007]) | 104 | 789 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT00041119
GET https://conductscience.org/api/trials/v1/NCT00041119/events?page=2