Trial · NCT00791037

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

NCT00791037, Phase 1, Phase 2, Completed, University of Washington; results first posted 2017-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vaccine Therapy in Treating Patients With Stage IV Breast Cancer. Trials, record NCT00791037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00791037

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vaccine Therapy in Treating Patients With Stage IV Breast Cancer
NCT number: NCT00791037
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 23 participants, actual
Lead sponsor: University of Washington
Conditions: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Interventions: HER-2/neu peptide vaccine, leukapheresis, ex vivo-expanded HER2-specific T cells, cyclophosphamide, sargramostim, laboratory biomarker analysis
First posted: 2008-11-14
Last updated: 2017-05-25
Results first posted: 2017-05-25
Limitations and caveats: All Other Adverse Events are reported regardless of attribution.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Up to 4 months after first booster vaccine	Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur.
Secondary	Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT	Up to 2 year following the last infusion
Secondary	Development of CD4+ and CD8+ Epitope Spreading	Up to 2 years	As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens.
Secondary	Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)	Up to 2 years

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	Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Up to 4 months after first booster vaccine	The infusion of escalating doses of HER2 specific T cells will be defined as safe if at least 75% of subjects are able to receive all 3 infusions without dose limiting toxicity (DLT)	participants	NUMBER
SECONDARY	Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT	Up to 2 year following the last infusion		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Development of CD4+ and CD8+ Epitope Spreading	Up to 2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)	Up to 2 years	Due to getting regulatory approvals we could only enroll 1 patient in this part of the protocol	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)	0	participants
Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT	Treatment (Vaccine Therapy)	15	Participants
Development of CD4+ and CD8+ Epitope Spreading	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	12	Participants
Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	1	Participants

Source ClinicalTrials.gov

Participant flow5

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	23
Overall Study	Primary Outcome	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	19
Overall Study	Skeletal or Bone-only Disease by FDG-PET	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	1
Overall Study	COMPLETED	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	23
Overall Study	NOT COMPLETED	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	0

Source ClinicalTrials.gov

Adverse events69

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	Abdominal pain	Gastrointestinal disorders	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	3	23	4
other	Alkaline phos increased	Investigations	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	2	23	3
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	2	23	3
other	Alanine aminotransferase	Investigations	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	3	23	3
other	Anorexia	Metabolism and nutrition disorders	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	7	23	8
other	Arthralgia	Musculoskeletal and connective tissue disorders	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	6	23	6
other	Aspartate aminotransferase increase	Investigations	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	8	23	9
other	Back pain	Musculoskeletal and connective tissue disorders	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	3	23	6
other	Bone pain	Musculoskeletal and connective tissue disorders	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	6	23	17
other	Hypocalcemia	Metabolism and nutrition disorders	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	5	23	5

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)
Total, other adverse events	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	23	23
Total, serious adverse events	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)	1	23

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27190628	DERIVED

Source PubMed

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
R01CA129517	Adoptive T Cell Therapy for the Treatment of HER2 Overexpressing Cancers	DISIS, MARY L.	UNIVERSITY OF WASHINGTON	NATIONAL CANCER INSTITUTE	2008 to 2011

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00791037

GET https://conductscience.org/api/trials/v1/NCT00791037/events?page=2

API reference For AI assistants