Actively Recruiting
HER2 Vaccine for Locally Advanced Breast Cancer
Led by Pravin T.P Kaumaya · Updated on 2026-04-22
36
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
CONDITIONS
Official Title
HER2 Vaccine for Locally Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of informed consent
- Able to provide written informed consent and HIPAA authorization
- Histologically confirmed HER2 positive breast cancer
- Any estrogen or progesterone receptor status allowed
- HER2 positivity defined by IHC 3+ or IHC 2+ with FISH ratio > 2.0 or > 6 HER2 gene copies per cell
- High-risk disease including residual invasive carcinoma after neoadjuvant chemotherapy, inflammatory phenotype, clinical stage III, or locally recurrent disease treated locally
- Received at least six months of HER2 targeted therapy (trastuzumab, pertuzumab, TDM-1, neratinib, or others)
- Completed last dose of HER2 targeted therapy no more than 6 months before registration
- Completed last dose of chemotherapy or radiation at least 30 days prior with toxicity resolved to grade 2 or less except alopecia
- ECOG performance status between 0 and 2
- Adequate organ function: bilirubin <1.5 mg/dL (or <3.0 with Gilbert's disease), AST and ALT <2.0x upper limit, creatinine clearance >60 mL/min, ANC >1.0 K/mm3, platelets >100 K/mm3
- Adequate cardiac function with LVEF above institutional lower limit by echocardiogram or MUGA within 90 days
- Women of childbearing potential must have negative pregnancy test within 14 days
- Women of childbearing potential and men must agree to use effective contraception during study and 6 months after
- Acceptable birth control methods include abstinence, partner vasectomy, IUD, condoms with spermicide, diaphragm, cervical cap, or hormonal birth control
You will not qualify if you...
- Any distant disease recurrence
- Active malignancy other than breast cancer (prior malignancies without recurrence are allowed)
- Receiving or planned to receive adjuvant CDK4/6 inhibitor therapy
- Immediate hypersensitivity positive to MVF-HER-2 peptide vaccines
- Require or likely to require corticosteroids or other immunosuppressive drugs
- Active autoimmune diseases like rheumatoid arthritis, lupus, scleroderma, polymyositis or vasculitis (exceptions possible if disease controlled without immunosuppressives for 6 months)
- History of anaphylactic reactions to other vaccines
- Active infection requiring antibiotics within 3 weeks prior to treatment
- Known HIV, hepatitis B, or hepatitis C infection (except seropositivity from vaccination)
- Uncontrolled illness limiting safety or compliance, including active infection, heart failure, unstable angina, or arrhythmias
- Serious uncontrolled cardiopulmonary disorders or medical diseases (exceptions possible if controlled for 6 months)
- History of splenectomy
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
N
Niraj Shah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here