Trial · NCT00266110
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
NCT00266110, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer. Trials, record NCT00266110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00266110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
- NCT number
- NCT00266110
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Breast Cancer
- Interventions
- sargramostim, therapeutic autologous dendritic cells, trastuzumab, vinorelbine ditartrate
- First posted
- 2005-12-15
- Last updated
- 2018-09-12
- Results first posted
- 2017-05-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Response | 5-6 years | Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Generation of E75/E90 Tetramer-positive CD8+ T Cells | 13 weeks | Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for E75/E90 tetramer-positive CD8+ T cells |
| Secondary | Generation of Interferon Gamma Positive CD8+T Cells | 13 weeks | Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for interferon gamma positive CD8+ T cells |
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 | Number of Participants With Response | 5-6 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Generation of E75/E90 Tetramer-positive CD8+ T Cells | 13 weeks | One patient failed to have blood drawn for correlative studies following second vaccine. | Percentage | MEAN |
| SECONDARY | Generation of Interferon Gamma Positive CD8+T Cells | 13 weeks | Three subjects had insufficient samples due to early withdraw from study, and one subject was removed from study before the vaccine was administered. | percentage of cells | MEAN |
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 |
|---|---|---|---|---|---|
| Number of Participants With Response | Dendritic Cell Vaccine | 0 | Participants | ||
| Generation of E75/E90 Tetramer-positive CD8+ T Cells | Dendritic Cell Vaccine | 3.63 | Full Range .17 to 19.4 | Percentage | |
| Generation of Interferon Gamma Positive CD8+T Cells | Dendritic Cell Vaccine | 15.99 | Full Range 0.93 to 36.7 | percentage of cells |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dendritic Cell Vaccine | 17 | |
| Overall Study | COMPLETED | Dendritic Cell Vaccine | 10 | |
| Overall Study | NOT COMPLETED | Dendritic Cell Vaccine | 7 |
Source ClinicalTrials.gov
Adverse events42
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 | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Dendritic Cell Vaccine | 1 | 17 | |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | Dendritic Cell Vaccine | 1 | 17 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Dendritic Cell Vaccine | 1 | 17 | |
| other | Anorexia | Metabolism and nutrition disorders | Dendritic Cell Vaccine | 1 | 17 | |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Dendritic Cell Vaccine | 1 | 17 | |
| other | Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | Dendritic Cell Vaccine | 3 | 17 | |
| other | Creatinine | Investigations | Dendritic Cell Vaccine | 1 | 17 | |
| other | Diarrhea | Gastrointestinal disorders | Dendritic Cell Vaccine | 1 | 17 | |
| other | Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Dendritic Cell Vaccine | 2 | 17 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Dendritic Cell Vaccine | 6 | 17 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dendritic Cell Vaccine | 15 | 17 |
| Total, other adverse events | Dendritic Cell Vaccine | 12 | 17 |
| Total, serious adverse events | Dendritic Cell Vaccine | 2 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|---|
| P50CA058223 | SPORE in Breast Cancer | PEROU, CHARLES M; CAREY, LISA A | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 1992 to 2025 | NIH RePORTER |
| R21CA105837 | Multimodality Therapy for Metastatic Breast Cancer | SERODY, JONATHAN STUART | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 2005 to 2006 | 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/NCT00266110
GET https://conductscience.org/api/trials/v1/NCT00266110/events?page=2