HER2 Vaccine for Locally Advanced Breast Cancer

NCT06949410 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CTO-IUSCCC-0864
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; HER2-positive Breast Cancer

Keywords

vaccine; immune system; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0

  Number of adverse events as assessed by the NCI CTCAE v. 5.0

  through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)

• Immune Response

  Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296).

  through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)

Study Arms (1)

HER2 Vaccine Arm

EXPERIMENTAL

MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines are combined in 1.5 mg doses of each peptide into a 3.0 mg total dose. This is administered intramuscularly in the gluteus maximus once every 21 days for three doses, in alternating sides (i.e. left-\>right-\>left), with a booster administered at 6 months.

Drug: HER2 Vaccine

Interventions

HER2 Vaccine DRUG

MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines

HER2 Vaccine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864
• Histologically confirmed HER2 positive breast cancer
• Any Estrogen Receptor/Progesterone Receptor status is allowed.
• 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.
• High-risk disease defined as one of the following:
• Any residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant taxane and trastuzumab-based chemotherapy
• Inflammatory phenotype at the time of diagnosis per the treating physician
• Clinical stage III disease at the time of diagnosis per the treating physician and/or clinical imaging
• Locally recurrent disease and have undergone definitive local therapy
• Received at least six months of HER2 targeted therapy with trastuzmab +/- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting
• a. Any combination of HER2 targeted therapy in the curative setting is allowed, including neratinib or others on a clinical trial
• Completed last dose of HER2 targeted therapy no more than 6 months prior to registration
• Completed last dose of cytotoxic chemotherapy or radiation at least 30 days prior to registration with resolution of any prior toxicity to ≤ 2 with the exception of alopecia
• ECOG performance status of 0 to 2

You may not qualify if:

• Any distant disease recurrence.
• Patients with active malignancy other than breast cancer. Note: Patients with prior malignancies without recurrence after standard treatment will not be excluded.
• Patients receiving or planned to receive adjuvant CDK4/6 inhibitor therapy
• Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.
• Patients who require or likely to require corticosteroids or other immunosuppressives
• 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.
• Patients who have developed anaphylactic responses to other vaccines.
• Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.
• Known seropositive or active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV). Seropositivity due to vaccination are eligible.
• Uncontrolled illness that would limit safety or compliance with study procedures including, but not limited to, active infection, congestive heart failure, unstable angina, or cardiac arrhythmia.
• Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.
• History of splenectomy
• Pregnant or breast feeding.

Sponsors & Collaborators

• Pravin T.P Kaumaya: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CHP-HER2 vaccine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pravin Kaumaya, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niraj Shah

CONTACT

317-278-3420; shahnir@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Vera Bradley Foundation Endowed Chair in Breast Cancer Innovation Professor of Microbiology & Immunology

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)