A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

NCT04144023 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: MC1713NCI-2019-0700216-010561
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.

Conditions

Breast Ductal Carcinoma In Situ

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Number of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

  2 years

• Dose limiting toxicities

  Measured using criteria from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 with grade \>= 3 allergic reaction, grade \>= 3 autoimmune reaction (except for autoimmune encephalitis grade \>=4), grade \>= 3 injection site reaction manifesting as an ulceration, grade \>= 3 neurologic problem, grade \>= 3 non-hematologic or cardiac toxicity, or changes in left ventricular ejection fraction (LVEF) as specified per protocol.

  14 days post vaccination, 2 years

Study Arms (1)

Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)

EXPERIMENTAL

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.

Biological: Granulocyte-Macrophage Colony-Stimulating Factor; Biological: Multi-epitope HER2 Peptide Vaccine H2NVAC; Procedure: Therapeutic Conventional Surgery; Procedure: Echocardiography Test; Procedure: Biospecimen Collection; Procedure: Biopsy Procedure

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor BIOLOGICAL

Given intradermally

Also known as: Colony Stimulating Factor 2, Colony Stimulating Factor, Granulocyte-Macrophage, Colony-Stimulating Factor, Colony-Stimulating Factor 2, CSF, CSF2, GM CSF, GM-CSF, GMCSF, Granulocyte Macrophage Colony Stimulating Factor, Granulocyte Macrophage Colony-Stimulating Factor, Granulocyte-Macrophage Colony Stimulating Factor

Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)

Multi-epitope HER2 Peptide Vaccine H2NVAC BIOLOGICAL

Given intradermally

Also known as: H2NVAC, HER2 Peptide Vaccine H2NVAC, HER2 Specific Helper T-cell Epitope Vaccine H2NVAC

Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)

Therapeutic Conventional Surgery PROCEDURE

Undergo standard of care surgery

Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)

Echocardiography Test PROCEDURE

Undergo ECHO

Also known as: EC, ECHOCARDIOGRAPHY, ECHO

Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)

Biopsy Procedure PROCEDURE

Undergo biopsy

Also known as: BIOPSY, BIOPSY_TYPE

Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors; Specimen Handling; Biopsy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Amy C. Degnim, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: June 27, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (2)