Trial · NCT00856492
S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer
NCT00856492, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2017-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer. Trials, record NCT00856492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00856492
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer
- NCT number
- NCT00856492
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 215 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Breast Cancer
- Interventions
- bevacizumab, pegfilgrastim, cyclophosphamide, doxorubicin hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation
- First posted
- 2009-03-05
- Last updated
- 2017-06-27
- Results first posted
- 2017-06-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Pathological Complete Response Rate | pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization) | Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes. |
| Secondary | Overall Survival | Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration. | Time from registration to death due to any cause |
| Secondary | Event-free Survival | Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence | Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause. |
| Secondary | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Up to 28 weeks | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Pathological Complete Response Rate | pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization) | Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration. | Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab | deaths | NUMBER |
| SECONDARY | Event-free Survival | Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence | Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab | participants | NUMBER |
| SECONDARY | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Up to 28 weeks | All participants receiving at least some protocol treatment | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Pathological Complete Response Rate | Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 35 | Participants | ||
| Number of Patients With Pathological Complete Response Rate | Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | 24 | Participants | ||
| Overall Survival | Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 14 | deaths | ||
| Overall Survival | Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | 17 | deaths | ||
| Event-free Survival | Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 20 | participants | ||
| Event-free Survival | Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | 24 | participants | ||
| Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Abdominal pain | 2 | Participants | |
| Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Arm II (Nab-Paclitaxel - AC+PEG-G) | Abdominal pain | 0 | Participants | |
| Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Arm III (AC+PEG-G - Nab-Paclitaxel) | Abdominal pain | 0 | Participants | |
| Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Adult respiratory distress syndrome | 1 | Participants |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 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 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)) | 99 | |
| Overall Study | STARTED | Arm 2 (Nab-Paclitaxel / AC+PEG-G) | 63 | |
| Overall Study | STARTED | Arm 3 (AC+PEG-G / Nab-Paclitaxel) | 53 | |
| Overall Study | Toxicity Eval | Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)) | 96 | |
| Overall Study | Toxicity Eval | Arm 2 (Nab-Paclitaxel / AC+PEG-G) | 60 | |
| Overall Study | Toxicity Eval | Arm 3 (AC+PEG-G / Nab-Paclitaxel) | 51 | |
| Overall Study | COMPLETED | Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)) | 98 | |
| Overall Study | COMPLETED | Arm 2 (Nab-Paclitaxel / AC+PEG-G) | 62 | |
| Overall Study | COMPLETED | Arm 3 (AC+PEG-G / Nab-Paclitaxel) | 51 | |
| Overall Study | NOT COMPLETED | Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)) | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events468
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 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 73 | 96 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Nab-Paclitaxel - AC+PEG-G) | 43 | 60 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III (AC+PEG-G - Nab-Paclitaxel) | 48 | 51 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 7 | 96 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Nab-Paclitaxel - AC+PEG-G) | 4 | 60 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm III (AC+PEG-G - Nab-Paclitaxel) | 3 | 51 | |
| other | Sinus tachycardia | Cardiac disorders | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 5 | 96 | |
| other | Sinus tachycardia | Cardiac disorders | Arm II (Nab-Paclitaxel - AC+PEG-G) | 1 | 60 | |
| other | Sinus tachycardia | Cardiac disorders | Arm III (AC+PEG-G - Nab-Paclitaxel) | 2 | 51 | |
| other | Ear pain | Ear and labyrinth disorders | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 4 | 96 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | ||
| Total, all-cause mortality | Arm II (Nab-Paclitaxel - AC+PEG-G) | ||
| Total, all-cause mortality | Arm III (AC+PEG-G - Nab-Paclitaxel) | ||
| Total, other adverse events | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 92 | 96 |
| Total, other adverse events | Arm II (Nab-Paclitaxel - AC+PEG-G) | 58 | 60 |
| Total, other adverse events | Arm III (AC+PEG-G - Nab-Paclitaxel) | 50 | 51 |
| Total, serious adverse events | Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 22 | 96 |
| Total, serious adverse events | Arm II (Nab-Paclitaxel - AC+PEG-G) | 3 | 60 |
| Total, serious adverse events | Arm III (AC+PEG-G - Nab-Paclitaxel) | 3 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) vs Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)): Event-free Survival | Trial comparisons |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) vs Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)): Number of Patients With Pathological Complete Response Rate | Trial comparisons |
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/NCT00856492
GET https://conductscience.org/api/trials/v1/NCT00856492/results?page=2