Phase I Trial of a Chimeric (Trastuzumab-like and Pertuzumab-like) HER2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant for Locally Advanced HER2 Positive Breast Cancer
Pravin T.P Kaumaya
Summary
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 axill…
Interventions
- DrugHER2 Vaccine
MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines
Location
- Indiana University Melvin & Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana