HER2/neu DNA Immunization for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Hormone therapy, Trastuzumab

Must not be taking: Corticosteroids

Disqualifiers: Pregnancy, Cardiac disease, Active cancers, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help the immune system fight breast cancer using a DNA injection targeting the HER2 protein. The goal is to determine if this approach is safe and can effectively trigger an immune response. It is specifically for breast cancer patients with high levels of HER2 on their tumor surfaces, who are either at an advanced stage (Stage III or IV) or have stable disease after treatment. Participants may have previously received treatments such as trastuzumab (Herceptin). This trial provides a unique opportunity for those seeking new treatment options, including xenogeneic HER2/Neu DNA immunization. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Do I need to stop my current medications to join the trial?

The trial allows patients to continue taking hormonal therapy and trastuzumab (Herceptin) during the study. However, if you are taking medications like corticosteroids that might affect your immune response, you may be excluded from the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining the safety and effectiveness of a new treatment called Xenogeneic HER2/Neu DNA immunization for breast cancer. This treatment involves injecting a small piece of DNA to help the immune system recognize and attack cancer cells with high levels of HER2/neu on their surface.

Limited published information exists on the safety of this treatment, as it remains in the early stages of study. Researchers are primarily focused on assessing patient tolerance. In these initial studies, the main goal is to identify any side effects and ensure the treatment's safety for people. Treatments in early stages are closely monitored to manage any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, which often include chemotherapy, hormone therapy, and monoclonal antibodies targeting HER2, the Xenogeneic HER2/Neu DNA Immunization works by teaching the immune system to recognize and attack cancer cells. This treatment uses a new mechanism of action by introducing foreign DNA that codes for the HER2 protein, effectively training the immune system to target cells expressing this protein more efficiently. Researchers are excited because this approach has the potential to offer a more targeted and long-lasting immune response with fewer side effects compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that the HER2/neu DNA vaccine, tested in this trial, might help the immune system combat breast cancer. In earlier studies, patients tolerated the vaccine well, and it triggered a strong immune response. Some patients even experienced a partial reduction in their tumors for up to six months. These early findings suggest that the vaccine can help the body’s defenses target cancer cells. The treatment is currently being tested in this trial to determine if it can safely enhance the immune system against tumors with high levels of HER2/neu. ^{1 3 4 6 7}

Who Is on the Research Team?

Mark Robson, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Stage III or metastatic breast cancer that has high levels of HER2. Participants must have finished previous treatments at least 4 weeks prior, can be on hormone therapy/trastuzumab, and should not have severe organ dysfunction or other active cancers. Pregnant women and those with certain heart conditions are excluded.

Inclusion Criteria

Pathology slides must be reviewed by the Department of Pathology at MSKCC

I am currently on hormonal therapy.

I am currently taking or have taken Herceptin for my cancer.

Exclusion Criteria

It is expected that you may not live for more than 6 months.

I have a history of heart disease, including heart attack, heart failure, or other heart conditions.

You have a history of a weakened immune system or a condition where your immune system attacks your body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of HER2/neu DNA to evaluate safety and immune response stimulation

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MAB HER 2 (HERCEPTIN)
• Xenogeneic HER2/Neu DNA Immunization

Trial Overview The study tests the safety and immune response to an injected DNA vaccine containing a gene for rat HER2 protein. It aims to immunize patients against their own tumor cells by stimulating antibody and T-cell production in individuals with high HER2 expression tumors.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

HER2 ECD DNA.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00393783?tab=history&a=11

Record History | ver. 11: 2010-01-21 | NCT00393783 Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity. Official ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2933838/

Anti-HER2 vaccines: new prospects for breast cancer therapy The vaccine was well tolerated and a significant anti-HER2 cellular response was observed. One patient had a partial tumor response for 6 months and disease ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X22002791

Immunogenicity of a xenogeneic multi-epitope HER2 + ... Our results suggest that using HER2 xenogeneic multi-epitope targeted to DCs for the development of breast cancer DNA vaccines may open new ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7828795/

Cancer Vaccines, Treatment of the Future: With Emphasis ... Results concluded that the 5-year disease-free survival (DFS) was 89.7% for those who received E75 and 80.2% in those who received placebo, ...

5. clinicaltrial.be clinicaltrial.be/en/details/13679?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Xenogeneic HER2/Neu DNA Immunization for Patients ... The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response.

6. clinicaltrial.be clinicaltrial.be/en/details/13679?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Xenogeneic HER2/Neu DNA Immunization for Patients ... The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response.

7. clin.larvol.com clin.larvol.com/trial-detail/NCT00393783

A Phase I Study to Assess Safety and Immunogenicity Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity. P1.