Trial · NCT00433511
Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer
NCT00433511, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2019-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer. Trials, record NCT00433511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433511
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer
- NCT number
- NCT00433511
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 4,994 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Breast Adenocarcinoma
- Interventions
- Bevacizumab, Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Placebo Administration, Quality-of-Life Assessment
- First posted
- 2007-02-12
- Last updated
- 2026-10-01
- Results first posted
- 2019-09-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease-free Survival (IDFS) Rate at 5 Years | Assessed at 5 years | Invasive disease-free survival (IDFS) was defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation. |
| Secondary | 5-year Overall Survival (OS) | Assessed at 5 years | Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive. |
| Secondary | The Association Between IDFS and Genotype | Assessed at 3 years | Invasive disease-free survival (IDFS) is defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation. Three-year IDFS rate was reported by genetic ancestry and IDFS was compared between patients with European ancestry and patients with African ancestry. |
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 | Invasive Disease-free Survival (IDFS) Rate at 5 Years | Assessed at 5 years | All randomized patients at Step 1 | proportion of participants | NUMBER |
| SECONDARY | 5-year Overall Survival (OS) | Assessed at 5 years | All randomized patients at Step 1 | proportion of participants | NUMBER |
| SECONDARY | The Association Between IDFS and Genotype | Assessed at 3 years | Only patients with genetic ancestry as European ancestry or African ancestry were included in the analysis. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Invasive Disease-free Survival (IDFS) Rate at 5 Years | Arm A (Chemo + Placebo) | 0.77 | 95% Confidence Interval 0.71 to 0.81 | proportion of participants | |
| Invasive Disease-free Survival (IDFS) Rate at 5 Years | Arm B (Chemo + Bevacizumab) | 0.76 | 95% Confidence Interval 0.72 to 0.80 | proportion of participants | |
| Invasive Disease-free Survival (IDFS) Rate at 5 Years | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 0.80 | 95% Confidence Interval 0.77 to 0.83 | proportion of participants | |
| 5-year Overall Survival (OS) | Arm A (Chemo + Placebo) | 0.90 | 95% Confidence Interval 0.87 to 0.92 | proportion of participants | |
| 5-year Overall Survival (OS) | Arm B (Chemo + Bevacizumab) | 0.86 | 95% Confidence Interval 0.83 to 0.88 | proportion of participants | |
| 5-year Overall Survival (OS) | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 0.90 | 95% Confidence Interval 0.88 to 0.92 | proportion of participants | |
| The Association Between IDFS and Genotype | European Ancestry | 0.887 | 95% Confidence Interval 0.875 to 0.900 | proportion of participants | |
| The Association Between IDFS and Genotype | African Ancestry | 0.832 | 95% Confidence Interval 0.793 to 0.872 | proportion of participants |
Source ClinicalTrials.gov
Participant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Step 1 | STARTED | Arm A (Chemo + Placebo) | 1,000 | |
| Step 1 | STARTED | Arm B (Chemo + Bevacizumab) | 1,986 | |
| Step 1 | STARTED | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 2,008 | |
| Step 1 | Patients Who Received Treatment | Arm A (Chemo + Placebo) | 972 | |
| Step 1 | Patients Who Received Treatment | Arm B (Chemo + Bevacizumab) | 1,922 | |
| Step 1 | Patients Who Received Treatment | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 1,942 | |
| Step 1 | Patients in Genetic Ancestry Analysis | Arm A (Chemo + Placebo) | 575 | |
| Step 1 | Patients in Genetic Ancestry Analysis | Arm B (Chemo + Bevacizumab) | 1,126 | |
| Step 1 | Patients in Genetic Ancestry Analysis | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 1,158 | |
| Step 1 | COMPLETED | Arm A (Chemo + Placebo) | 864 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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 | Left ventricular systolic dysfunction | Cardiac disorders | Arm A (Chemo + Placebo) | 37 | 972 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | Arm B (Chemo + Bevacizumab) | 103 | 1,922 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 87 | 1,942 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | Arm D (Bevacizumab Cycles 9-18 of Arm C) | 64 | 1,168 | |
| other | Neuropathy-sensory | Nervous system disorders | Arm A (Chemo + Placebo) | 188 | 972 | |
| other | Neuropathy-sensory | Nervous system disorders | Arm B (Chemo + Bevacizumab) | 356 | 1,922 | |
| other | Neuropathy-sensory | Nervous system disorders | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 334 | 1,942 | |
| other | Neuropathy-sensory | Nervous system disorders | Arm D (Bevacizumab Cycles 9-18 of Arm C) | 182 | 1,168 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm A (Chemo + Placebo) | 52 | 972 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm B (Chemo + Bevacizumab) | 117 | 1,922 |
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 A (Chemo + Placebo) | ||
| Total, all-cause mortality | Arm B (Chemo + Bevacizumab) | ||
| Total, all-cause mortality | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | ||
| Total, all-cause mortality | Arm D (Bevacizumab Cycles 9-18 of Arm C) | ||
| Total, other adverse events | Arm A (Chemo + Placebo) | 245 | 972 |
| Total, other adverse events | Arm B (Chemo + Bevacizumab) | 513 | 1,922 |
| Total, other adverse events | Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 479 | 1,942 |
| Total, other adverse events | Arm D (Bevacizumab Cycles 9-18 of Arm C) | 233 | 1,168 |
| Total, serious adverse events | Arm A (Chemo + Placebo) | 473 | 972 |
| Total, serious adverse events | Arm B (Chemo + Bevacizumab) | 1,090 | 1,922 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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/NCT00433511
GET https://conductscience.org/api/trials/v1/NCT00433511/flow?page=2