Trial · NCT00093795
Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer
NCT00093795, Phase 3, Completed, NSABP Foundation Inc; results first posted 2017-12-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer. Trials, record NCT00093795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00093795
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer
- NCT number
- NCT00093795
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,894 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Breast Cancer
- Interventions
- Cyclophosphamide, Docetaxel, Gemcitabine, Paclitaxel, Doxorubicin
- First posted
- 2004-10-08
- Last updated
- 2018-01-11
- Results first posted
- 2017-12-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer | 5 years | The percentage of patients alive and cancer-free. |
| Secondary | Overall Survival | 5 years | Percentage of participants alive at 5 years |
| Secondary | Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence | 5 years | Percentage of patients recurrence-free (no first local, regional, or distant recurrence) |
| Secondary | Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only | 5 years | Percentage of patients distant recurrence-free (no distant disease recurrence only) |
| Secondary | Toxicity | 30 days after the last dose of study therapy (about 7 months after study entry) | Percentage of patients who ever experienced grade 2 or higher toxicities. |
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 | Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer | 5 years | For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants. | percentage of patients | NUMBER |
| SECONDARY | Overall Survival | 5 years | For Arm 1 there is no follow-up data for 13 participants; for Arm 2 there is no follow-up data for 10 participants; and for Arm 3 there is no follow-up data for 12 participants. | percentage of patients alive | NUMBER |
| SECONDARY | Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence | 5 years | For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants. | percentage of patients | NUMBER |
| SECONDARY | Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only | 5 years | For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants. | percentage of patients | NUMBER |
| SECONDARY | Toxicity | 30 days after the last dose of study therapy (about 7 months after study entry) | For Arm 1 there is no follow-up data for 23 participants; for Arm 2 there is no follow-up data for 11 participants; and for Arm 3 there is not follow-up data for 18 participants. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer | Group 1: TAC X 6 | 80.1 | 95% Confidence Interval 78.0 to 82.0 | percentage of patients | |
| Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer | Group 2: AC X 4 Then P X 4 | 82.2 | 95% Confidence Interval 80.2 to 84.0 | percentage of patients | |
| Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer | Group 3: AC X 4 Then PG X 4 | 80.6 | 95% Confidence Interval 78.5 to 82.5 | percentage of patients | |
| Overall Survival | Group 1: TAC X 6 | 89.6 | 95% Confidence Interval 88.1 to 91.1 | percentage of patients alive | |
| Overall Survival | Group 2: AC X 4 Then P X 4 | 89.1 | 95% Confidence Interval 87.4 to 90.5 | percentage of patients alive | |
| Overall Survival | Group 3: AC X 4 Then PG X 4 | 90.8 | 95% Confidence Interval 89.3 to 92.1 | percentage of patients alive | |
| Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence | Group 1: TAC X 6 | 85.1 | 95% Confidence Interval 83.2 to 86.9 | percentage of patients | |
| Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence | Group 2: AC X 4 Then P X 4 | 86.2 | 95% Confidence Interval 84.3 to 87.9 | percentage of patients | |
| Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence | Group 3: AC X 4 Then PG X 4 | 84.8 | 95% Confidence Interval 82.8 to 86.5 | percentage of patients | |
| Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only | Group 1: TAC X 6 | 86.6 | 95% Confidence Interval 84.7 to 88.2 | percentage of patients |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: TAC X 6 | 1,630 | |
| Overall Study | STARTED | Group 2: AC X 4 Then P X 4 | 1,634 | |
| Overall Study | STARTED | Group 3: AC X 4 Then PG X 4 | 1,630 | |
| Overall Study | COMPLETED | Group 1: TAC X 6 | 1,610 | |
| Overall Study | COMPLETED | Group 2: AC X 4 Then P X 4 | 1,618 | |
| Overall Study | COMPLETED | Group 3: AC X 4 Then PG X 4 | 1,613 | |
| Overall Study | NOT COMPLETED | Group 1: TAC X 6 | 20 | |
| Overall Study | NOT COMPLETED | Group 2: AC X 4 Then P X 4 | 16 | |
| Overall Study | NOT COMPLETED | Group 3: AC X 4 Then PG X 4 | 17 |
Source ClinicalTrials.gov
Adverse events375
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 | Abdominal pain | Gastrointestinal disorders | TAC X 6 | 93 | 1,601 | |
| other | Abdominal pain | Gastrointestinal disorders | AC X 4 Then P X 4 | 67 | 1,612 | |
| other | Abdominal pain | Gastrointestinal disorders | AC X 4 Then PG X 4 | 87 | 1,604 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | TAC X 6 | 27 | 1,601 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | AC X 4 Then P X 4 | 73 | 1,612 | |
| other | Alanine aminotransferase increased (ALT/SGPT) | Investigations | AC X 4 Then PG X 4 | 108 | 1,604 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | TAC X 6 | 267 | 1,601 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | AC X 4 Then P X 4 | 484 | 1,612 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | AC X 4 Then PG X 4 | 446 | 1,604 | |
| other | Constipation | Gastrointestinal disorders | TAC X 6 | 154 | 1,601 |
1 to 10 of 375Source ClinicalTrials.gov
See all 375 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAC X 6 | ||
| Total, all-cause mortality | AC X 4 Then P X 4 | ||
| Total, all-cause mortality | AC X 4 Then PG X 4 | ||
| Total, other adverse events | TAC X 6 | 1,231 | 1,601 |
| Total, other adverse events | AC X 4 Then P X 4 | 1,322 | 1,612 |
| Total, other adverse events | AC X 4 Then PG X 4 | 1,323 | 1,604 |
| Total, serious adverse events | TAC X 6 | 277 | 1,601 |
| Total, serious adverse events | AC X 4 Then P X 4 | 158 | 1,612 |
| Total, serious adverse events | AC X 4 Then PG X 4 | 187 | 1,604 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23940225 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| U10CA012027 | NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT | WOLMARK, NORMAN | NSABP FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 1985 to 2012 |
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/NCT00093795
GET https://conductscience.org/api/trials/v1/NCT00093795/events?page=2