RECRUITING

HER2 Vaccine for Locally Advanced Breast Cancer

Conditions

Breast Cancer HER2-positive Breast Cancer vaccine immune system immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-10

Study Completion:2030-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06949410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 HER2 targeted therapy with trastuzmab +/- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting 6. Completed last dose of HER2 targeted therapy no more than 6 months prior to registration 7. 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 8. ECOG performance status of 0 to 2 9. Adequate organ function as indicated by: 1. Total bilirubin \< 1.5 mg/dL (except in patients with documented Gilbert's disease, who must have a total bilirubin \< 3.0 mg/dL) 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.0 x ULN 3. Calculated creatinine clearance of \> 60 mL/min using the Cockcroft-Gault formula 4. Absolute neutrophil count (ANC) \> 1.0 K/mm3 5. Platelets \> 100 K/ mm3 10. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) above the institutional lower limit of normal by echocardiogram or MUGA obtained within 90 days of registration 11. Women of childbearing potential must have a negative serum pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria: 1. Has undergone a hysterectomy or bilateral oophorectomy; or 2. Has been naturally amenorrheic for at least 12 consecutive months. 12. Women of childbearing potential and men must agree to use one effective contraception throughout the study and for 6 months after the last study treatment.	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. 7. Patients who have developed anaphylactic responses to other vaccines. 8. 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. 9. Known seropositive or active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV). Seropositivity due to vaccination are eligible. 10. 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. 11. 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. 12. History of splenectomy 13. Pregnant or breast feeding.

Inclusion Criteria

Exclusion 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 HER2 targeted therapy with trastuzmab +/- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting
6. Completed last dose of HER2 targeted therapy no more than 6 months prior to registration
7. 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
8. ECOG performance status of 0 to 2
9. Adequate organ function as indicated by:
1. Total bilirubin \< 1.5 mg/dL (except in patients with documented Gilbert's disease, who must have a total bilirubin \< 3.0 mg/dL)
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.0 x ULN
3. Calculated creatinine clearance of \> 60 mL/min using the Cockcroft-Gault formula
4. Absolute neutrophil count (ANC) \> 1.0 K/mm3
5. Platelets \> 100 K/ mm3
10. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) above the institutional lower limit of normal by echocardiogram or MUGA obtained within 90 days of registration
11. Women of childbearing potential must have a negative serum pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
1. Has undergone a hysterectomy or bilateral oophorectomy; or
2. Has been naturally amenorrheic for at least 12 consecutive months.
12. Women of childbearing potential and men must agree to use one effective contraception throughout the study and for 6 months after the last study treatment.

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.
7. Patients who have developed anaphylactic responses to other vaccines.
8. 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.
9. Known seropositive or active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV). Seropositivity due to vaccination are eligible.
10. 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.
11. 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.
12. History of splenectomy
13. Pregnant or breast feeding.

Contacts and Locations

Study Contact

Niraj Shah

CONTACT

317-278-3420

shahnir@iu.edu

Principal Investigator

Pravin Kaumaya, PhD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Pravin T.P Kaumaya

Pravin Kaumaya, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10

Study Completion Date2030-03

Study Record Updates

Study Start Date2025-10

Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

vaccine
immune system
immunotherapy

Additional Relevant MeSH Terms

Breast Cancer
HER2-positive Breast Cancer