Vaccine for Breast Cancer Recurrence

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: HER-2 targeted therapy

Must not be taking: Immunosuppressants, Systemic corticosteroids

Disqualifiers: Uncontrolled illness, Autoimmune, HIV, Hepatitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two vaccines, DC1 and WOKVAC, to determine if they can safely prevent the recurrence of breast cancer. The research aims to discover if these vaccines can help individuals remain cancer-free for longer periods. Participants will receive one of these vaccines in two phases: an initial phase and a booster phase. The trial seeks individuals with HER2-positive breast cancer who have undergone specific chemotherapy and are either still on or have recently completed HER2-targeted therapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not be on extended use of immunosuppressive agents or systemic corticosteroids, and you should not be participating in another clinical trial with experimental therapy.

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

Research has shown that both the DC1 and WOKVAC vaccines are generally safe and well-tolerated. One study found that the DC1 vaccine did not cause serious side effects and helped the immune system identify and attack cancer cells. Another study found that the WOKVAC vaccine is safe and can create a strong immune response. Earlier trials tested both vaccines and did not reveal major harmful effects. Overall, evidence suggests these vaccines are safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the DC1 and WOKVAC vaccines for breast cancer recurrence because they offer a novel approach compared to traditional treatments like chemotherapy and hormone therapy. Unlike these standard options, which target cancer cells directly, both vaccines work by stimulating the immune system to recognize and attack cancer cells, potentially providing a more targeted response. The DC1 Vaccine utilizes dendritic cells, which are key players in the immune system, to enhance this immune response. Similarly, the WOKVAC uses specific proteins associated with cancer growth to trigger an immune response. This immunotherapy approach could lead to fewer side effects and improved long-term outcomes for patients.

What evidence suggests that this trial's vaccines could be effective for preventing breast cancer recurrence?

This trial will compare two vaccines for breast cancer recurrence. Research has shown that the DC1 vaccine, which participants in this trial may receive, helps the body identify and fight breast cancer cells by preventing tumors from hiding from the immune system, potentially shrinking them. The WOKVAC vaccine, another option in this trial, has also demonstrated a strong immune response and proved safe in early tests. Both vaccines aim to prevent cancer from returning by enhancing the immune system's ability to target cancer cells. Overall, studies indicate that both vaccines are well tolerated and show promise in reducing cancer recurrence. ^{2 3 6 7 8}

Who Is on the Research Team?

Hyo Han, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HER-2 positive breast cancer who've had neoadjuvant chemotherapy and still have some invasive carcinoma. They must be on or recently finished HER-2 targeted therapy, have normal organ/marrow function, agree to contraception use, and not be pregnant. Exclusions include hypersensitivity to GM-CSF adjuvant, HIV/hepatitis B/C infection, major surgery within the last month, other clinical trials participation, uncontrolled illnesses or extended immunosuppressant/corticosteroid use.

Inclusion Criteria

I still have cancer in my breast or underarm area after chemotherapy before surgery.

I have stage I-III HER2 positive breast cancer and received specific treatment for over 12 weeks.

I finished my last chemotherapy or radiation over a month ago and have recovered from the side effects.

Exclusion Criteria

You have been diagnosed with HIV.

I have not had major surgery in the last 4 weeks.

I am not on long-term steroids or immunosuppressants, except for minimal local use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive the initial study vaccine

6 months

Regular visits for vaccine administration

Booster

Participants receive booster vaccines approximately 6 months after the initial vaccine

6 months

3 booster visits

Follow-up

Participants are monitored for disease recurrence and survival

2 years

Every 6 months (phone call/secure email, medical records or follow-up visit)

What Are the Treatments Tested in This Trial?

Interventions

• DC1 Vaccine
• WOKVAC Vaccine

Trial Overview The study compares two vaccines (DC1 vs. WOKVAC) designed to prevent breast cancer recurrence in patients with a history of HER-2 positive disease. Participants will receive one vaccine during a vaccination phase followed by a booster phase. The main goal is to see how well these vaccines work in extending the time before any potential return of cancer.

How Is the Trial Designed?

Group I: Dendritic Cell (DC1) Vaccine Active Control 1 Intervention

The vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.

Group II: pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) Active Control 1 Intervention

The vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A dendritic cell vaccine targeting the ErbB-2/neu oncogene showed protective immunity in about 60% of tested mice, indicating its potential as a therapeutic strategy for breast cancer.

The vaccine's effectiveness was enhanced when combined with IL-12, demonstrating that optimizing immune responses through cytokine co-delivery can improve treatment outcomes against tumors that overexpress ErbB-2/neu.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of ErbB-2/neu-specific protective and therapeutic antitumor immunity using genetically modified dendritic cells: enhanced efficacy by cotransduction of gene encoding IL-12. Chen, Y., Emtage, P., Zhu, Q., et al.[2019]

In a study involving 13 patients with HER-2/neu positive ductal carcinoma in situ (DCIS), a dendritic cell vaccine targeting HER-2/neu led to significant immune responses, with 85% of patients developing CD4+ T cells and 80% developing CD8+ T cells that recognized breast cancer cells.

Post-vaccination, many patients exhibited reduced HER-2/neu expression in tumor samples, indicating that the vaccine may effectively induce an immune response capable of 'immunoediting' tumor cells, suggesting its potential for both prevention and treatment of early breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. Czerniecki, BJ., Koski, GK., Koldovsky, U., et al.[2021]

An autologous dendritic cell (DC) vaccine developed for breast cancer showed promising in vitro efficacy, eliciting a strong cytotoxic T-lymphocyte response against autologous breast cancer cells in 12 female patients with early-stage disease.

The matured DCs demonstrated significant upregulation of activation markers and produced high levels of the cytokine IL12-p70, indicating their potential effectiveness in stimulating the immune response, and they maintained viability and safety after cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An autologous dendritic cell vaccine polarizes a Th-1 response which is tumoricidal to patient-derived breast cancer cells. Tomasicchio, M., Semple, L., Esmail, A., et al.[2020]

Breast cancer vaccines targeting oncodrivers are being tested in clinical trials, showing potential as a cost-effective preventive measure against both initial and recurring disease.

Despite modest clinical response rates, these vaccines have provided important insights into tumor immunology, paving the way for future developments in effective breast cancer immunotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine Therapies for Breast Cancer. Burke, EE., Kodumudi, K., Ramamoorthi, G., et al.[2020]

Dendritic cell (DC) vaccines have shown considerable anti-tumor effects in breast cancer treatment, with some already in clinical trials, highlighting their potential as a promising immunotherapy option.

This review discusses the immunomodulatory effects and mechanisms of DC vaccines, suggesting that while they offer new avenues for treatment, there are still challenges to overcome in their development and application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dendritic cell vaccines in breast cancer: Immune modulation and immunotherapy. Qian, D., Li, J., Huang, M., et al.[2023]

Citations

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A systematic review of the efficacy of cancer vaccines in ... The primary outcome was safety, while secondary outcomes included PFS and peptide-specific immune induction. Main characteristics are presented ...

2. nature.com nature.com/articles/s41523-025-00742-x

A pilot study incorporating HER2-directed dendritic cells ... These HER2 DC1 vaccines can reverse tumor mediated immunosuppression, re-establish recognition of HER2 epitopes, and lead to the regression of ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.532

A multicenter phase II study of vaccines to prevent ... Conclusions: Both DC1 and WOKVAC HER2 vaccines were well tolerated without significant toxicities. Updated results will be presented at the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332225000526

The power of dendritic cell-based vaccines in immunotherapy This review offers a comprehensive analysis of the present-day progress in dendritic cell (DC)-based vaccines and recent efforts to enhance their efficacy.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03384914

NCT03384914 | Vaccine to Prevent Recurrence in Patients ... The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11914126/

A pilot study incorporating HER2-directed dendritic cells ... These HER2 DC1 vaccines can reverse tumor mediated immunosuppression, re-establish recognition of HER2 epitopes, and lead to the regression of ...

7. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT02061423/

Clinical Trial: NCT02061423 The primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3330145/

HER-2 Pulsed Dendritic Cell Vaccine Can Eliminate ... Results suggest vaccination against HER-2/neu is safe, well-tolerated and induces decline and or eradication of HER-2/neu expression. These findings warrant ...