RecruitingBreast CancerHER2-positive Breast Cancer

HER2 Vaccine for Locally Advanced Breast Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.

Sponsor: Pravin T.P Kaumaya

✓ 1. ≥ 18 years old at the time of informed consent
✓ 2. Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864
✓ 3. Histologically confirmed HER2 positive breast cancer
✓ 1. Any Estrogen Receptor/Progesterone Receptor status is allowed.
✓ 2. HER2 positive is defined as HER2 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \> 2.0 or \> 6 total HER2 gene copies per cell.
✓ 4. High-risk disease defined as one of the following:
✓ 1. Any residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant taxane and trastuzumab-based chemotherapy
✓ 2. Inflammatory phenotype at the time of diagnosis per the treating physician

✕ 1. Any distant disease recurrence.
✕ 2. Patients with active malignancy other than breast cancer. Note: Patients with prior malignancies without recurrence after standard treatment will not be excluded.
✕ 3. Patients receiving or planned to receive adjuvant CDK4/6 inhibitor therapy
✕ 4. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.
✕ 5. Patients who require or likely to require corticosteroids or other immunosuppressives
✕ 6. Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.
✕ Note: At the discretion of the treating physician, patients who show disease control for at least 6 months and do not require immunosuppressives may be enrolled.
✕ 7. Patients who have developed anaphylactic responses to other vaccines.

Indianapolis

Source: ClinicalTrials.gov · NCT06949410 · last updated 2026-04-22