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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

43 Participants
are divided into 1 treatment group

Sponsors and collaborators