A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
NCT ID: NCT04144023
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
43 participants
INTERVENTIONAL
2019-06-27
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy
NCT02061423
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
NCT00496808
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
NCT02063724
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
NCT00194714
Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2
NCT00363012
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the safety and tolerability of multi-epitope HER2 peptide vaccine H2NVAC (H2NVAC) given for 4 treatments in patients with HER2-expressing ductal carcinoma in situ (DCIS) prior to surgery.
II. To determine the dose level of H2NVAC with maximum systemic and intratumoral immunogenicity as measured by activated HER2-specific T lymphocytes or high-affinity antibodies.
SECONDARY OBJECTIVES:
I. To determine intratumoral immunogenicity of H2NVAC in patients with HER2-expressing DCIS.
II. To assess the complete pathological response after 4 treatments of neoadjuvant H2NVAC.
III. To assess the systemic immunogenicity of H2NVAC in patients with HER2-expressing DCIS.
IV. To assess changes in HER2 expression in the DCIS after 4 treatments of neoadjuvant H2NVAC.
V. To assess the distribution of the helper T cell response among T helper cell differentiation states.
OUTLINE: This is a dose-escalation study of multi-epitope HER2 peptide vaccine H2NVAC followed by a dose expansion study for dose level.
Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive granulocyte macrophage-colony-stimulating factor (GM-CSF) admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo echocardiography (ECHO) and collection of blood samples throughout the trial and may undergo biopsy on trial.
After completion of study treatment, patients are followed up at 3, 6, and 12 months after surgery and optionally at 18 and 24 months after surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)
Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo ECHO and collection of blood samples throughout the trial and may undergo biopsy on trial.
Echocardiography Test
Undergo ECHO
Biospecimen Collection
Undergo collection of blood samples
Biopsy Procedure
Undergo biopsy
Granulocyte-Macrophage Colony-Stimulating Factor
Given intradermally
Multi-epitope HER2 Peptide Vaccine H2NVAC
Given intradermally
Therapeutic Conventional Surgery
Undergo standard of care surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Echocardiography Test
Undergo ECHO
Biospecimen Collection
Undergo collection of blood samples
Biopsy Procedure
Undergo biopsy
Granulocyte-Macrophage Colony-Stimulating Factor
Given intradermally
Multi-epitope HER2 Peptide Vaccine H2NVAC
Given intradermally
Therapeutic Conventional Surgery
Undergo standard of care surgery
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must not have received any prior therapy for current DCIS
* Note: Patients who received tamoxifen, raloxifene, aromatase inhibitor or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least 2 months prior to baseline study biopsy if they chose to have this collected
* Note: Concurrent use of endocrine therapy during the vaccination/preoperative period is not allowed. However, standard adjuvant endocrine therapy with tamoxifen or aromatase inhibitor after completion of vaccination and surgery is allowed
* Any degree of HER2 expression as performed on the diagnostic clinical biopsy defined by immunohistochemistry +1, +2, or +3
* Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis
* Note: suspected microinvasion or definite microinvasion (\< 0.1 mm invasion) on core biopsy is allowed
* Patients will be asked to have an additional research biopsy prior to the first vaccination. This is not mandatory for participation
* Patients must have evidence of at least 0.5 cm of disease extent based on mammogram, ultrasound, or magnetic resonance (MRI) imaging
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (less than or equal to 28 days prior to registration)
* Platelet count \>= 75,000/mm\^3 (less than or equal to 28 days prior to registration)
* Hemoglobin \>= 9.0 g/dL (less than or equal to 28 days prior to registration)
* Creatinine =\< 2 x upper limit of normal (ULN) (less than or equal to 28 days prior to registration)
* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2 x ULN (less than or equal to 28 days prior to registration)
* Albumin \>= 3 g/dL (less than or equal to 28 days prior to registration)
* Negative serum pregnancy test done =\< 7 days prior to Registration, for women of childbearing potential only
* 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, or abstinence
* 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 for all study visits (immunizations, blood draws, etc)
* Willing to provide blood samples for correlative research purposes
* Willing to receive a tetanus vaccination if subject has not had one within the past year
Exclusion Criteria
* Pregnant women
* Nursing women unwilling to stop breast feeding
* 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, unless physiologic replacement for adrenal or pituitary insufficiency
* Note: Must be off systemic steroids greater than or equal to 90 days prior to Registration. However, topical steroids, inhalants 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:
* 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 less than or equal to 6 months prior to registration
* Receiving any other investigational agent
* Other active malignancy at time of registration or less than or equal to the last three years prior to registration. EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ (e.g. 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 active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration
* NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded
* Any prior hypersensitivity or adverse reaction to 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
* History of ipsilateral radiation to the current affected breast with DCIS
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amy C. Degnim
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amy C. Degnim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2019-07002
Identifier Type: REGISTRY
Identifier Source: secondary_id
16-010561
Identifier Type: OTHER
Identifier Source: secondary_id
MC1713
Identifier Type: -
Identifier Source: org_study_id
NCT03793829
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.