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RecruitingPhase 1NCT06949410

HER2 Vaccine for Locally Advanced Breast Cancer

Trial Parameters

ConditionBreast Cancer
SponsorPravin T.P Kaumaya
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment36
SexALL
Min Age18 Years
Max AgeN/A
Start Date2026-03
Completion2029-12
Interventions
HER2 Vaccine

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Brief Summary

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

Eligibility Criteria

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 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 3. Clinical stage III disease at the time of diagnosis per the treating physician and/or clinical imaging 4. Locally recurrent disease and have undergone definitive local therapy 5. Received at least six months of HER

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