HER2-positive Breast CancerPhase 2NCT00343109
Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer
A Phase 2 study testing HER-2/neu intracellular domain protein, leukapheresis and laboratory biomarker analysis 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 is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV 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 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, Male Breast Cancer, Stage IIIB Breast Cancer
- What is being tested?
- HER-2/neu intracellular domain protein, leukapheresis and laboratory biomarker analysis
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jun 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IIIB or Stage IIIC breast cancer who are within 1 year of diagnosis and initiating treatment with chemotherapy and trastuzumab; and are in complete remission
- Stage IV breast cancer in first complete remission and defined as NED (no evidence of disease) or with stable bone only disease who are within 6 months of initiating maintenance trastuzumab
- NED status should be documented by chest/abdominal CT, PET or PET/CT within the last 90 days
- Bone only disease documented as stable or healed by PET, PET/CT, or MRI within the last 90 days; stable bone-only disease must be documented with bone scan performed within the last 6 months
- HER2 overexpression by IHC of 2+ or 3+, in the primary tumor or metastasis or documented gene amplification by FISH analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
- Eligible subjects must have been treated to NED or stable bone only disease status with trastuzumab and/or chemotherapy and be off cytotoxic chemotherapy or immunosuppressive agents (e.g. systemic steroids) for at least 30 days prior to enrollment (concurrent hormonal therapy allowed; concurrent bisphosphonate therapy allowed)
Show all 19Show fewer
- Patients on trastuzumab should continue trastuzumab monotherapy per standard of care (the dosing and schedule of trastuzumab should follow standard guidelines as described below: trastuzumab 2mg/kg IV weekly or trastuzumab 6mg/kg IV every 3 weeks)
- Subjects must have an ECOG Performance Status Score =< 1
- Non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
- Male subjects must use an acceptable form of contraception throughout the course of the study
- Hematocrit >= 30,000
- Platelet count >= 100,000
- WBC >= 3000/mcl
- Stable creatinine =< 2.0 mg/dl or a creatinine clearance greater than 60 ml/min
- Serum bilirubin < 1.5 mg/dl
- SGOT < 2x ULN
- Laboratory tests should be performed within 60 days of enrollment
- Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
- Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) on MUGA scan or echocardiogram performed within last 6 months
Who cannot join
- Subjects cannot be simultaneously enrolled in other treatment studies
- Patients cannot be receiving any other concurrent immunomodulators besides trastuzumab
- Any contraindication to receiving GM-CSF based vaccine products
- Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
- Active autoimmune disease
- Subjects can not have active immunodeficiency disorder, e.g. HIV
- Cannot be pregnant or breast feeding
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 of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV 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 estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine.
SECONDARY OBJECTIVES:
- To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab.
- To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab.
- To determine the incidence of the development of T cell immunity specific for the HER2 ICD.
- To determine the incidence of the development of intramolecular epitope spreading.
- To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response generated with immunization.
- To assess whether there is an association between RFS and the development of an immune response (HER2 specific T cell immunity and/or the development of intramolecular epitope spreading).
OUTLINE:
Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally (ID) once monthly for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 4, 8, and 12 months and then annually thereafter for up to 5 years.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Being tested
- HER-2/neu intracellular domain protein, leukapheresis, laboratory biomarker analysis, sargramostim, immunologic technique
- 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 intracellular domain proteinBiological
Also called HER-2 ICD Peptide, HER-2/neu ICD Protein
Given ID
leukapheresisProcedure or surgery
Optional correlative studies
laboratory biomarker analysisOther
Correlative studies
sargramostimBiological
Also called GM-CSF, Leukine, Prokine
Given ID
immunologic techniqueOther
Also called immunological laboratory methods, laboratory methods, immunological
Correlative studies
synthetic tumor-associated peptide vaccine therapyBiological
Given ID
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally once monthly for 6 months in the absence of disease progression or unacceptable toxicity. Receives: Biological: HER-2/neu intracellular domain protein; Procedure: leukapheresis; Other: laboratory biomarker analysis; Biological: sargramostim; Other: immunologic technique; Biological: synthetic tumor-associated peptide vaccine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Measured: At 4 years
Secondary outcomes (3)
Safety as assessed by NCI CTCAE version 3.0
Measured: Baseline and 1 month following last vaccination
Immune response as assessed by HER2 specific T cell immunity and/or intramolecular epitope spreading
Measured: Baseline, midpoint in the immunization schedule (prior to the 4th vaccine), 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations
Correlation of RFS to the generation of an immune response
Measured: Prior to the 4th vaccine, 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startMar 2004
- Primary completionJun 2015
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mary Disis, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343109
- Sponsor's protocol ID
- 6166 (FH/UWCC ID)
- Other IDs
- NCI-2010-00803, BC 030289, 120
- Status last verified
- May 2019
- First submitted
- 20 Jun 2006
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00343109
- Acronym / sponsor ID
- 6166 (FH/UWCC ID)
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- Jun 2015 (actual)
- First posted
- 22 Jun 2006 (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 is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Detailed description
PRIMARY OBJECTIVES:
- To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine.
SECONDARY OBJECTIVES:
- To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab.
- To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab.
- To determine the incidence of the development of T cell immunity specific for the HER2 ICD.
- To determine the incidence of the development of intramolecular epitope spreading.
- To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response generated with immunization.
- To assess whether there is an association between RFS and the development of an immune response (HER2 specific T cell immunity and/or the development of intramolecular epitope spreading).
OUTLINE:
Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally (ID) once monthly for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 4, 8, and 12 months and then annually thereafter for up to 5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: HER-2/neu intracellular domain protein, Procedure: leukapheresis, Other: laboratory biomarker analysis, Biological: sargramostim, Other: immunologic technique, Biological: synthetic tumor-associated peptide vaccine therapyPatients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally once monthly for 6 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Stage IIIB or Stage IIIC breast cancer who are within 1 year of diagnosis and initiating treatment with chemotherapy and trastuzumab; and are in complete remission
- Stage IV breast cancer in first complete remission and defined as NED (no evidence of disease) or with stable bone only disease who are within 6 months of initiating maintenance trastuzumab
- NED status should be documented by chest/abdominal CT, PET or PET/CT within the last 90 days
- Bone only disease documented as stable or healed by PET, PET/CT, or MRI within the last 90 days; stable bone-only disease must be documented with bone scan performed within the last 6 months
- HER2 overexpression by IHC of 2+ or 3+, in the primary tumor or metastasis or documented gene amplification by FISH analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
Key exclusion criteria (7 listed)
- Subjects cannot be simultaneously enrolled in other treatment studies
- Patients cannot be receiving any other concurrent immunomodulators besides trastuzumab
- Any contraindication to receiving GM-CSF based vaccine products
- Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
- Active autoimmune disease
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 intracellular domain proteinAlso: HER-2 ICD Peptide, HER-2/neu ICD ProteinGiven ID | Biological | Arm I |
| leukapheresisOptional correlative studies | Procedure or surgery | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I |
| sargramostimAlso: GM-CSF, Leukine, ProkineGiven ID | Biological | Arm I |
| immunologic techniqueAlso: immunological laboratory methods, laboratory methods, immunologicalCorrelative studies | Other | Arm I |
| synthetic tumor-associated peptide vaccine therapyGiven ID | Biological | Arm I |
Primary outcome
Relapse-free survival
Time frame: At 4 years
3 secondary outcomes
Safety as assessed by NCI CTCAE version 3.0
Time frame: Baseline and 1 month following last vaccination
Immune response as assessed by HER2 specific T cell immunity and/or intramolecular epitope spreading
Time frame: Baseline, midpoint in the immunization schedule (prior to the 4th vaccine), 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations
Correlation of RFS to the generation of an immune response
Time frame: Prior to the 4th vaccine, 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Related trials for HER2-positive Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
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.
Mary Disis 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 intracellular domain protein, leukapheresis and laboratory biomarker analysis 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 19 inclusion and 7 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: finished, as of the sponsor's last update on 12 Feb 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relapse-free survival (time frame: At 4 years). 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 12 Feb 2020.