Vaccine Therapy for Breast Cancer

Recruiting at 1 trial location

Overseen By Xin Bryan, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pravin T.P Kaumaya

Must not be taking: Targeted therapies

Disqualifiers: Active infection, HIV, Hepatitis, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: up to 92 days

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and optimal dose of a new vaccine therapy for individuals with advanced breast or gastrointestinal cancers. The vaccine, called the Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720, aims to help the immune system target and destroy cancer cells. It may suit those whose cancer has progressed after standard treatments and who have specific HER-2 or EGFR markers, proteins found on some cancer cells. Participants should have had limited prior chemotherapy and be open to trying an experimental treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, patients on certain targeted therapies or those requiring corticosteroids or other immunosuppressives are not eligible, which might imply some restrictions. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the HER-2 vaccine, made from two specific proteins, is generally safe for people with advanced solid tumors. In previous studies, patients tolerated this vaccine well. Researchers tested the vaccine by mixing it with montanide ISA 720, a substance that enhances its effectiveness.

Most participants did not experience serious side effects. Common reactions included mild skin issues at the injection site, such as redness or swelling, similar to other vaccines. No severe side effects were directly linked to the vaccine. Overall, the vaccine demonstrated a promising safety profile, causing no significant harm to participants in these earlier studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about these treatments because they target the HER-2 protein, which is overexpressed in some breast cancers. Unlike the standard chemotherapy or hormonal therapies, which often have broad effects, these vaccines aim to train the immune system specifically against cancer cells overexpressing HER-2. This targeted approach could potentially offer a more precise treatment with fewer side effects. Additionally, the use of a vaccine therapy is a novel strategy in breast cancer treatment, aiming to harness the body’s own defenses to fight the disease, which is a promising advancement in cancer care.

What evidence suggests that this vaccine therapy might be an effective treatment for breast cancer?

This trial will evaluate the HER-2 vaccine, which uses two special small proteins, MVF-HER2 266-296 and MVF-HER2 597-626, to help the body's immune system fight cancer cells. Participants will receive the vaccine, designed to strengthen the immune response to better target and destroy cancer cells. Early research suggests this method might be effective against both breast and gastrointestinal cancers. Although limited data from human studies exist, the vaccine's approach is promising as it aims to train the immune system to attack tumor cells. ^{1 2 3 4 6}

Who Is on the Research Team?

Pravin Kaumaya, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for patients with metastatic solid tumors, specifically those with breast cancer or gastrointestinal cancers that show an overexpression of a protein called Epidermal Growth Factor Receptor (EGFR).

Inclusion Criteria

I have breast or gastrointestinal cancer that cannot be removed by surgery.

I had brain metastases treated, off steroids, and stable for 3+ months.

Women of child-bearing potential must not be pregnant and must have a negative pregnancy test. Men and women must agree to practice effective contraception while on this study

Exclusion Criteria

I am allergic to specific components used in the trial.

I have been off antibiotics for 3 weeks and am clear of infection.

Patients who have developed anaphylactic responses to other vaccines

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HER-2 B Cell Peptide Vaccine to study side effects and best dose

up to 92 days

Multiple visits for vaccine administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 1 year

Follow-up visits at 21 days, 6 months, and 1 year post initial vaccination

What Are the Treatments Tested in This Trial?

Interventions

• Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720

Trial Overview The study is testing vaccine therapy combining two peptides, MVF-HER-2 (597-626) and MVF-HER-2 (266-296), mixed with ISA 720 to see if it can stimulate the immune system to destroy tumor cells.

How Is the Trial Designed?

Group I: HER-2 vaccine GI Experimental Treatment 1 Intervention

Group II: HER-2 vaccine Breast Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Pravin T.P Kaumaya

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

A multiepitope vaccine targeting the HER-2 oncoprotein was developed using computer-aided analysis, which showed promising results in inducing high levels of antibodies that inhibited tumor growth in rabbits.

Combining two specific chimeric vaccines enhanced immune responses, leading to a significant reduction in pulmonary metastases in a cancer model, suggesting potential for treating HER-2-associated cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A chimeric multi-human epidermal growth factor receptor-2 B cell epitope peptide vaccine mediates superior antitumor responses. Dakappagari, NK., Pyles, J., Parihar, R., et al.[2020]

The E75 vaccine demonstrated significant effectiveness in improving immune responses and clinical outcomes, such as reduced recurrence rates and increased disease-free survival in breast cancer patients, with minimal side effects reported.

The GP2 vaccine also showed promise in eliciting immune responses, particularly in increasing CD8+ T-cell numbers, but further clinical trials are necessary to establish its efficacy compared to the E75 vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of HER2 peptide vaccines in patients with breast cancer: a systematic review and meta-analysis. You, Z., Zhou, W., Weng, J., et al.[2021]

In a study of 39 elderly patients with HER-2-positive breast cancer, 82.1% completed one year of trastuzumab treatment, indicating good tolerance to the therapy.

While 28.2% experienced adverse events, including congestive heart failure and lower left ventricular ejection fraction, most patients managed to recover with appropriate treatment, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of adjuvant trastuzumab for HER-2-overexpressing elderly breast cancer patients: a multicenter cohort study. Sawaki, M., Mukai, H., Tokudome, N., et al.[2015]

HER2-targeted therapies, like trastuzumab, have shown promising immunomodulatory effects that can enhance the treatment of HER2-overexpressing cancers, but more options are still needed.

Preclinical studies indicate that combining HER2-targeted therapies with immunotherapies, such as checkpoint inhibitors and cancer vaccines, may provide synergistic benefits, particularly in specific patient populations like those with PD-L1+ breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy as a partner for HER2-directed therapies. Clifton, GT., Peoples, AGE.[2022]

The AE37 vaccine, which targets the HER-2/neu protein in breast cancer, has been shown to be safe and effective in generating long-lasting immune responses in patients, regardless of their HER-2/neu expression levels.

Early clinical trials indicate that the AE37 vaccine may help prevent breast cancer recurrence, highlighting its potential as a promising immunotherapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AE37: a novel T-cell-eliciting vaccine for breast cancer. Sears, AK., Perez, SA., Clifton, GT., et al.[2014]

In a study involving female BALB/c mice, the combination of the MUC1 gene vaccine and GM-CSF adjuvant significantly inhibited the growth of EMT6 breast cancer tumors, with tumor sizes reduced to 135 mm³ compared to 596 mm³ in the control group.

The presence of GM-CSF not only enhanced the overall antitumor effect of the MUC1 vaccine but also increased the cytotoxicity of MUC1-specific T cells, demonstrating a more effective immune response against the cancer cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Enhanced inhibitory effect of MUC1 gene vaccine on breast cancer growth by GM-CSF]. Yuan, SF., Li, KZ., Wang, L., et al.[2019]

In a phase III trial involving 758 women with HER2 low-expressing breast cancer, the combination of nelipepimut-S (NP-S) and GM-CSF was well tolerated, with common side effects being mild injection site reactions.

The interim analysis showed no significant difference in disease-free survival (DFS) between the NP-S group and the placebo group, although NP-S did lead to a higher detection rate of recurrence events through imaging in asymptomatic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Mittendorf, EA., Lu, B., Melisko, M., et al.[2020]

The dHER2 immunotherapeutic combined with the AS15 immunostimulant was well tolerated in 40 patients with HER2-positive metastatic breast cancer, showing minimal toxicity and no cardiac events, which is important for patient safety.

Clinical activity was demonstrated with one complete response lasting 11 months and one partial response lasting 3.5 months, along with stable disease in 10 patients for at least 26 weeks, indicating potential efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/II trial of the safety and clinical activity of a HER2-protein based immunotherapeutic for treating women with HER2-positive metastatic breast cancer. Curigliano, G., Romieu, G., Campone, M., et al.[2021]

E75, an immunogenic peptide from the HER2 protein, has been shown to be safe and effective in stimulating an immune response in breast cancer patients when used as a vaccine with an immunoadjuvant.

In a study of 187 patients, those vaccinated with E75 + GM-CSF had a 5-year disease-free survival rate of 89.7%, significantly higher than the 80.2% in the control group, indicating a 48% reduction in the risk of cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Development of the E75 Vaccine in Breast Cancer. Clifton, GT., Gall, V., Peoples, GE., et al.[2020]

Recent trials show that new HER2-targeted agents like pertuzumab and trastuzumab emtansine (T-DM1) are effective in treating HER2-positive breast cancer, with T-DM1 being a powerful combination of trastuzumab and a cytotoxic agent.

Combining trastuzumab with lapatinib or pertuzumab has led to significantly better outcomes, nearly doubling the rates of complete response in patients, indicating a shift towards dual anti-HER2 therapies to overcome resistance in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging strategies for the dual inhibition of HER2-positive breast cancer. Konecny, GE.[2019]

The combination of the HER2-based vaccine dHER2 and lapatinib was found to be safe for patients with HER2-overexpressing metastatic breast cancer, showing no cardiotoxicity and inducing anti-HER2-specific antibodies in all participants (n=12).

Despite a median time to progression of 55 days, the treatment demonstrated promising long-term survival, with a 300-day overall survival rate of 92%, indicating potential effectiveness in patients who are refractory to trastuzumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 clinical trial of HER2-specific immunotherapy with concomitant HER2 kinase inhibition [corrected]. Hamilton, E., Blackwell, K., Hobeika, AC., et al.[2023]

The GP2 vaccine, when administered with GM-CSF, was found to be safe with minimal toxicities in a phase II trial involving 180 breast cancer patients, indicating its potential for use in clinical settings.

Although the overall analysis did not show a significant benefit in disease-free survival compared to the control group, there were promising results in patients with HER2 overexpression, suggesting that the vaccine may be more effective in this subgroup when the full treatment series is completed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary analysis of a prospective, randomized, single-blinded phase II trial evaluating the HER2 peptide GP2 vaccine in breast cancer patients to prevent recurrence. Mittendorf, EA., Ardavanis, A., Litton, JK., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7159438/

Phase 1 Immunotherapy Trial with Two Chimeric HER-2 B ... The combination vaccine was prepared by mixing the two chimeric MVF-B-cell epitope peptides that correspond to amino acid sequences 266–296 ( ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-05515

Chimeric HER2 B-cell Peptide Vaccine Emulsified in ... Vaccines made from MVF-HER2 266-296 and MVF HER2 597-626 peptides may help the body build an effective immune response to kill tumor cells. Montanide ISA 720, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06414733

NCT06414733 | HER-2 B Cell Peptide Vaccine This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-03029

A Combined Vaccine (MVF-HER-2 [597-626] and ... This phase Ib trial tests the safety side effects, and effectiveness of a combined vaccine therapy (MVF-HER-2 [597-626] and MVF-HER-2 [266-296]) in treating ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06949410

HER2 Vaccine for Locally Advanced Breast Cancer 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 ( ...

6. aacrjournals.org aacrjournals.org/clincancerres/article-abstract/25/12/3495/264250

Phase I Immunotherapy Trial with Two Chimeric HER-2 B-Cell ... This first-in-human phase I study (NCT 01417546) evaluated the safety profile, optimal immunologic/biological dose (OID/OBD), and immunogenicity of the ...