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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT04144023
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Breast Ductal Carcinoma In Situ

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Granulocyte-Macrophage Colony-Stimulating Factor — BIOLOGICAL
    Given intradermally
  • Multi-epitope HER2 Peptide Vaccine H2NVAC — BIOLOGICAL
    Given intradermally
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo standard of care surgery
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy

Study Details

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.

Key Dates

Start date
Jun 27, 2019
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Adverse events [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-766-0015
Saranya Chumsri, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Amy C. Degnim, M.D. (PRINCIPAL_INVESTIGATOR)

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