HER2-positive Breast CancerPhase 2NCT01729884
Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer
A Phase 2 study testing HER-2/neu peptide vaccine in people with HER2-positive Breast Cancer and Male Breast Cancer, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- HER-2/neu peptide vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission
- Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below:
- Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques
- Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI)
- Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy
- HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis
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- Patients must be human leukocyte antigen (HLA)-A2 positive
- Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1
- Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine
- Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >= the lower limit of normal for the facility within 3 months of enrollment to study
- Subjects of reproductive ability must agree to use contraceptives during the entire study period
Who cannot join
- White blood cell (WBC) < 3000/mm^3
- Hemoglobin (Hgb) < 10 mg/dl
- Platelets < 100,000/mm^3
- Serum creatinine > 2.0 mg/dl
- Serum bilirubin > 1.5 x upper limit of normal
- Any contraindication to receiving sargramostim (GM-CSF) based vaccine products
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- Concurrent enrollment in other treatment studies
- New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina
- Pregnant or breast-feeding women
- History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV)
- Active brain metastasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer
This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL) peptide-based vaccine.
II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based vaccine and characterize their function.
SECONDARY OBJECTIVES:
- To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).
OUTLINE:
Patients receive HER-2/neu peptide vaccine intradermally (ID) once monthly for 3 months.
After completion of study treatment, patients are followed up at 4 weeks.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Being tested
- HER-2/neu peptide vaccine
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2/neu peptide vaccineBiological
Also called HER-2
Given ID
| Study group | Role | What they receive |
|---|---|---|
| Treatment (HER-2/neu peptide vaccine) | Experimental | Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months. Receives: Biological: HER-2/neu peptide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
Wilson score 90% confidence intervals will be reported.
Measured: Up to 4 weeks
Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets
Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
Measured: Up to 4 weeks
Secondary outcomes (2)
The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
All, severe or worse, serious and related events will be quantified.
Measured: Up to 4 weeks
The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0
All, severe or worse, serious and related events will be quantified.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
Why it stopped: Study ended early due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary (Nora) Disis, University of Washington
- Investigators
- Lupe Salazar, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729884
- Sponsor's protocol ID
- 7905
- Other IDs
- NCI-2012-02223, 7905, P30CA015704, P50CA138293
- Status last verified
- Apr 2017
- First submitted
- 15 Nov 2012
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT01729884
- Acronym / sponsor ID
- 7905
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ended early due to slow enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL) peptide-based vaccine.
II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based vaccine and characterize their function.
SECONDARY OBJECTIVES:
- To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).
OUTLINE:
Patients receive HER-2/neu peptide vaccine intradermally (ID) once monthly for 3 months.
After completion of study treatment, patients are followed up at 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (HER-2/neu peptide vaccine) | Experimental | Biological: HER-2/neu peptide vaccinePatients receive HER-2/neu peptide vaccine ID once monthly for 3 months. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission
- Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below:
- Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy
- HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis
- Patients must be human leukocyte antigen (HLA)-A2 positive
Key exclusion criteria (11 listed)
- White blood cell (WBC) < 3000/mm^3
- Hemoglobin (Hgb) < 10 mg/dl
- Platelets < 100,000/mm^3
- Serum creatinine > 2.0 mg/dl
- Serum bilirubin > 1.5 x upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HER-2/neu peptide vaccineAlso: HER-2Given ID | Biological | Treatment (HER-2/neu peptide vaccine) |
Primary outcome
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
Time frame: Up to 4 weeks
Wilson score 90% confidence intervals will be reported.
Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets
Time frame: Up to 4 weeks
Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
2 secondary outcomes
The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 4 weeks
The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0
Time frame: Up to 4 weeks
Results and safety
The study was stopped early (reason given: Study ended early due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lupe Salazar principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HER-2/neu peptide vaccine in people with HER2-positive Breast Cancer and Male Breast Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study ended early due to slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.