Trial · NCT00847171
Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer
NCT00847171, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2018-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer. Trials, record NCT00847171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00847171
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer
- NCT number
- NCT00847171
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Breast Cancer
- Interventions
allogeneic GM-CSF-secreting breast cancer vaccine, trastuzumab, cyclophosphamide, flow cytometry, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, biopsy
- First posted
- 2009-02-19
- Last updated
- 2018-09-26
- Results first posted
- 2018-09-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as Assessed by Number of Participants Experiencing Toxicity | 4 years | Safety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy. |
| Primary | Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides | 4 years | |
| Secondary | Clinical Benefit as Assessed by Number of Participants With Progression-free Survival | 4 years | Number of participants without evidence of disease progression. |
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 | Safety as Assessed by Number of Participants Experiencing Toxicity | 4 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides | 4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Benefit as Assessed by Number of Participants With Progression-free Survival | 4 years | Only 13/20 participants had early stage disease, and 7/20 participants had a history of metastatic disease at the start of the study. All participants were assigned to the same treatment group. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Safety as Assessed by Number of Participants Experiencing Toxicity | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | Patients with drug-related toxicity | 20 | Participants | |
| Safety as Assessed by Number of Participants Experiencing Toxicity | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | Patients with grade 3+ drug-related toxicity | 0 | Participants | |
| Safety as Assessed by Number of Participants Experiencing Toxicity | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | Patients with serious drug-related toxicity | 0 | Participants | |
| Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | DTH-positive at baseline | 12 | Participants | |
| Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | Increased DTH from baseline | 11 | Participants | |
| Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | Converted from DTH-negative to DTH-positive | 5 | Participants | |
| Clinical Benefit as Assessed by Number of Participants With Progression-free Survival | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | Patients with early stage disease | 12 | Participants | |
| Clinical Benefit as Assessed by Number of Participants With Progression-free Survival | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | Patients with metastatic disease | 6 | Participants |
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 | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 20 | |
| Overall Study | COMPLETED | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 20 | |
| Overall Study | NOT COMPLETED | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 0 |
Source ClinicalTrials.gov
Adverse events35
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 | Erythema/swelling of vaccine sites | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 20 | 20 | |
| other | Pain/soreness/tenderness of vaccine sites | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 20 | 20 | |
| other | Pruritus of vaccine sites | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 20 | 20 | |
| other | Blister at vaccine site | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 16 | 20 | |
| other | Dry skin at vaccine site | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 1 | 20 | |
| other | Ecchymosis at vaccine site | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 6 | 20 | |
| other | Eczema at vaccine site | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 1 | 20 | |
| other | Edema at vaccine site | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 1 | 20 | |
| other | Hives at vaccine site | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 2 | 20 | |
| other | Hyperpigmentation at vaccine site | Skin and subcutaneous tissue disorders | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 1 | 20 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 0 | 20 |
| Total, other adverse events | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 20 | 20 |
| Total, serious adverse events | Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 0 | 20 |
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 |
|---|---|---|---|---|---|
| P30CA006973 | Regional Oncology Research Center | NELSON, WILLIAM GEORGE | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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/NCT00847171
GET https://conductscience.org/api/trials/v1/NCT00847171/events?page=2