Trial · NCT00399529
Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of HER-2/Neu-Overexpressing Metastatic Breast Cancer
NCT00399529, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2020-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of HER-2/Neu-Overexpressing Metastatic Breast Cancer. Trials, record NCT00399529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00399529
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of HER-2/Neu-Overexpressing Metastatic Breast Cancer
- NCT number
- NCT00399529
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Breast Neoplasms
- Interventions
- Allogeneic GM-CSF-secreting breast cancer vaccine, Trastuzumab, Cyclophosphamide
- First posted
- 2006-11-15
- Last updated
- 2020-04-22
- Results first posted
- 2020-04-13
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 Adverse Events | From first dose through 30 days after last dose of study drug, up to 9 months | Safety is measured as the number of patients that experienced adverse events related to study drug. |
| Primary | Number of Participants With Clinical Benefit | At 6 and 12 months from start of treatment | Clinical benefit is defined as the proportion of patients achieving complete response, partial response, or stable disease by RECIST. Complete response (CR) is defined as total disappearance of all clinical evidence of reversible disease. A partial response (PR) is defined as a \>=30% reduction in tumor target lesions. Stable disease (SD) is defined as disease status that fails to qualify as as a response (CR or PR) or progressive disease (increase of at least 20% in tumor target lesions). |
| Secondary | Number of Participants With Delayed Type Hypersensitivity (Immunological Response) | 30 days after each vaccine, up to 9 months | The number of participants with a Delayed Type Hypersensitivity (DTH) response was measured as an indicator of immune response. Participants were considered to have a DTH response if they had increased induration (\>5mm from baseline) at the site of injection 2-3 days after intradermal injection with human epidermal growth factor receptor 2 (HER-2) peptides. This peptide injection was given 28 days after each dose of vaccine. |
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 Adverse Events | From first dose through 30 days after last dose of study drug, up to 9 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Clinical Benefit | At 6 and 12 months from start of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Delayed Type Hypersensitivity (Immunological Response) | 30 days after each vaccine, up to 9 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
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 Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Fatigue | 8 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Urticaria | 7 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Pruritus | 6 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Fever | 5 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Flu-like symptoms | 4 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Lymphadenopathy | 4 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Abdominal pain | 3 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Rash | 3 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Malaise | 3 | Participants | |
| Number of Participants With Adverse Events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | Chills | 3 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 22 | |
| Overall Study | COMPLETED | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 20 | |
| Overall Study | NOT COMPLETED | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 2 |
Source ClinicalTrials.gov
Adverse events30
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 | Fatigue | General disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 8 | 20 | |
| other | Urticaria | Skin and subcutaneous tissue disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 7 | 20 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 6 | 20 | |
| other | Fever | General disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 5 | 20 | |
| other | Flu-like symptoms | General disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 4 | 20 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 4 | 20 | |
| other | Abdominal Pain | Gastrointestinal disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 3 | 20 | |
| other | Rash | Skin and subcutaneous tissue disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 3 | 20 | |
| other | Malaise | General disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 3 | 20 | |
| other | Chills | General disorders | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 3 | 20 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 0 | 20 |
| Total, other adverse events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 20 | 20 |
| Total, serious adverse events | Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 1 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25116755 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT00399529
GET https://conductscience.org/api/trials/v1/NCT00399529/results?page=2