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

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.

Trial Details

NCT ID
NCT04144023
Phase
PHASE1
Sponsor
Mayo Clinic
Status
RECRUITING
Cancer Type
Lobular Carcinoma Breast Cancer
Interventions
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Multi-epitope HER2 Peptide Vaccine H2NVAC
  • Therapeutic Conventional Surgery
  • Echocardiography Test
  • Biospecimen Collection
  • Biopsy Procedure
Locations (sample)
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

  • 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 …
  • Note: Concurrent use of endocrine therapy during the vaccination/preoperative period is not allowed. However, standard adjuvant endocrine therapy w…

For full eligibility, visit ClinicalTrials.gov.

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