HER2-positive Breast CancerPhase 1NCT01632332
Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
A Phase 1 study testing HER-2/neu peptide vaccine and laboratory biomarker analysis in people with HER2-positive Breast Cancer and Male Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer. 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 II Breast Cancer
- What is being tested?
- HER-2/neu peptide vaccine and laboratory biomarker analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2012to 9 Jul 2018
- Phase
- Phase 1
- 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
- Histological confirmation of primary breast cancer, stage II or III, completely resected; Note: history of a local recurrence allowable if also completely resected
- Prior diagnosis of HER-2 positive primary breast cancer using American Society of Clinical Oncologists (ASCO)/College of American Pathologists (CAP) guidelines (either by evidence of 3+ immunohistochemical staining or with in situ hybridization [FISH] amplification)
- Completion of surgery +/- radiation at least 30 days prior to registration
- Must have received mastectomy or lumpectomy plus radiation
- Must have received either neoadjuvant and/or adjuvant chemotherapy for treatment of breast cancer
- Must have received either neoadjuvant and/or adjuvant trastuzumab for treatment of breast cancer
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- All chemotherapy, trastuzumab, and/or corticosteroids must be completed at least 90 days prior to registration; Note: hormonal therapy and bisphosphonates may be ongoing
- Clinically without any evidence of disease recurrence/progression (per practice guidelines for breast cancer)
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelet count >= 75,000/mm^3
- Hemoglobin >= 9.0 g/dL
- Creatinine =< 2 x upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x ULN
- Albumin >= 3 g/dL
- Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- Capable of understanding the investigative nature, potential risks, and benefits of the study
- Capable of providing valid informed consent
- Willing to return to enrolling institution (Mayo Clinic Rochester) for all study visits (immunizations, blood draws, etc)
- Willing to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle; Note: adequate contraception methods include birth control pills, barrier device, intrauterine device
- Willing to provide blood samples for correlative research purposes
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Willing to receive a tetanus vaccination if you have not had one within the past year
Who cannot join
- Any prior lapatinib or pertuzumab treatment
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women unwilling to stop breast feeding
- Men or women of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids; Note: must be off systemic steroids at least 90 days prior to registration; topical steroids or steroid eye drops are permitted Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Uncontrolled acute or chronic medical conditions including, but not limited to the following:
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- Active infection requiring antibiotics
- Congestive heart failure with New York Heart Association class III or IV; moderate to severe objective evidence of cardiovascular disease
- Myocardial infarction or stroke within previous 6 months Receiving any other investigational agent Other active malignancy at time of registration or within the last three years prior to registration; EXCEPTIONS: non-melanoma skin cancer or carcinoma-in-situ (eg of cervix, prostate); NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment (cytotoxics, monoclonal antibodies, small molecule inhibitors) for their cancer Known history of autoimmune disease, including Type I diabetes Any prior hypersensitivity or adverse reaction to granulocyte-macrophage colony-stimulating factor (GM-CSF) History of trastuzumab-related cardiac toxicity requiring interruption or discontinuation of therapy, even if left ventricular ejection fraction (LVEF) fully recovered Baseline LVEF with a value below 55% Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment History of myocardial infarction =< 168 days (6 months) prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias Bilateral invasive breast cancer, either synchronous or metachronous; Note: ductal carcinoma in situ in the contralateral breast is permissible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope HER-2/Neu Peptide Vaccine in Subjects Previously Treated for HER-2 Positive Breast Cancer
The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety profile of a peptide-based vaccine targeting HER-2/neu, in patients with stage II/III HER-2 positive breast cancer.
II. To determine the ability of this vaccination protocol to elicit an immune response as measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies.
SECONDARY OBJECTIVES:
- To compile descriptive follow-up data regarding vital status and disease recurrence.
II. To determine if HER-2/neu peptide 885 generates a T cell response that is specific to HER-2/neu or is cross-reactive with epidermal growth factor receptor (EGFR) protein.
III. To determine if the human leukocyte antigen (HLA)-DR epitopes contain HLA class I embedded epitopes.
OUTLINE:
Patients receive HER-2/neu peptide vaccine intradermally (ID) every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 2 additional years.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- HER-2/neu peptide vaccine, laboratory biomarker analysis
- 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
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (HER-2/neu peptide vaccine) | Experimental | Patients receive HER-2/neu peptide vaccine ID every 28 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity. Receives: Biological: HER-2/neu peptide vaccine; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience toxicities of attribution during the course of treatment (grades 3-5 of the NCI's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0) for 2 years.
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Measured: Assessed up to 2 years following final immunization
To determine the ability of this vaccination protocol to elicit an immune response as measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies
Immune responses to to the vaccine components will be periodically assessed using various assays measuring cytokine release, frequency of T cells, and antibody generation.
Measured: 30 months
Secondary outcomes (1)
Disease-free survival
Disease-free survival is defined as the time from registration to documentation of disease recurrence, second primary, or death without disease recurrence or second primary. The distribution of disease-free and overall survival times will be estimated using the method of Kaplan-Meier.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study start9 Jul 2012
- Primary completion24 Mar 2014
- Study completion9 Jul 2018
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 Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Marker Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Keith Knutson, Ph.D., Principal investigator, Mayo ClinicAmy Degnim, M.D., Principal investigator, Mayo ClinicKimberly Kalli, Ph.D., Study chair, Mayo ClinicTimothy Hobday, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632332
- Sponsor's protocol ID
- MC1136
- Other IDs
- NCI-2012-00963
- Status last verified
- Oct 2018
- First submitted
- 28 Jun 2012
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope HER-2/Neu Peptide Vaccine in Subjects Previously Treated for HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01632332
- Acronym / sponsor ID
- MC1136
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Marker Therapeutics, Inc.
- Study start
- 9 Jul 2012 (actual)
- Primary completion
- 24 Mar 2014 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 2 Jul 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.
The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety profile of a peptide-based vaccine targeting HER-2/neu, in patients with stage II/III HER-2 positive breast cancer.
II. To determine the ability of this vaccination protocol to elicit an immune response as measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies.
SECONDARY OBJECTIVES:
- To compile descriptive follow-up data regarding vital status and disease recurrence.
II. To determine if HER-2/neu peptide 885 generates a T cell response that is specific to HER-2/neu or is cross-reactive with epidermal growth factor receptor (EGFR) protein.
III. To determine if the human leukocyte antigen (HLA)-DR epitopes contain HLA class I embedded epitopes.
OUTLINE:
Patients receive HER-2/neu peptide vaccine intradermally (ID) every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 2 additional years.
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 vaccine, Other: laboratory biomarker analysisPatients receive HER-2/neu peptide vaccine ID every 28 days for up to 6 courses in the absence of disease recurrence 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 (22 listed)
- Histological confirmation of primary breast cancer, stage II or III, completely resected; Note: history of a local recurrence allowable if also completely resected
- Prior diagnosis of HER-2 positive primary breast cancer using American Society of Clinical Oncologists (ASCO)/College of American Pathologists (CAP) guidelines (either by evidence of 3+ immunohistochemical staining or with in situ hybridization [FISH] amplification)
- Completion of surgery +/- radiation at least 30 days prior to registration
- Must have received mastectomy or lumpectomy plus radiation
- Must have received either neoadjuvant and/or adjuvant chemotherapy for treatment of breast cancer
Key exclusion criteria (9 listed)
- Any prior lapatinib or pertuzumab treatment
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women unwilling to stop breast feeding
- Men or women of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids; Note: must be off systemic steroids at least 90 days prior to registration; topical steroids or steroid eye drops are permitted Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (HER-2/neu peptide vaccine) |
Primary outcome
Proportion of patients who experience toxicities of attribution during the course of treatment (grades 3-5 of the NCI's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0) for 2 years.
Time frame: Assessed up to 2 years following final immunization
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
To determine the ability of this vaccination protocol to elicit an immune response as measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies
Time frame: 30 months
Immune responses to to the vaccine components will be periodically assessed using various assays measuring cytokine release, frequency of T cells, and antibody generation.
1 secondary outcome
Disease-free survival
Time frame: 30 months
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 9 Oct 2018.
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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.
Keith Knutson, Ph.D. principal investigator
Mayo Clinic
Amy Degnim, M.D. principal investigator
Mayo Clinic
Kimberly Kalli, Ph.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HER-2/neu peptide vaccine and laboratory biomarker analysis in people with HER2-positive Breast Cancer and Male Breast Cancer, run by Mayo Clinic 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 22 inclusion and 9 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 9 Oct 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Proportion of patients who experience toxicities of attribution during the course of treatment (grades 3-5 of the NCI's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0) for 2 years. (time frame: Assessed up to 2 years following final immunization). 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 9 Oct 2018.