Vaccine for Breast Cancer Recurrence

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

119 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the DC1 Vaccine and WOKVAC Vaccine treatment for breast cancer recurrence?

Research shows that dendritic cell (DC) vaccines, like the DC1 Vaccine, can stimulate the immune system to attack breast cancer cells. Studies have demonstrated that these vaccines can lead to a strong immune response, reducing cancer markers and potentially decreasing tumor size in breast cancer patients. ^{1 2 3 4 5}

Is the DC1 Vaccine safe for humans?

Research on dendritic cell (DC) vaccines, including those targeting breast cancer, suggests they are generally safe and can effectively stimulate the immune system. Clinical studies have shown that DC vaccines can induce protective immune responses without significant safety concerns. ^{1 4 6 7 8}

How is the DC1 and WOKVAC vaccine treatment different from other breast cancer treatments?

The DC1 and WOKVAC vaccine treatment is unique because it uses a patient's own dendritic cells (a type of immune cell) to create a personalized vaccine that stimulates a strong immune response against breast cancer cells, potentially reducing recurrence. This approach is different from conventional treatments, which often involve chemotherapy or radiation, as it aims to harness the body's immune system to target and destroy cancer cells. ^{3 4 5 7 9}

What is the purpose of this trial?

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 (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Research Team

Hyo Han, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Dendritic cell vaccines in breast cancer: Immune modulation and immunotherapy. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Longitudinal analysis of DC subsets in patients with ovarian cancer: Implications for immunotherapy. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Vaccine Therapies for Breast Cancer. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

An autologous dendritic cell vaccine polarizes a Th-1 response which is tumoricidal to patient-derived breast cancer cells. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Dendritic cells in cancer immunotherapy. [2020]

7. England 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. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Direct T-cell Presentation by cDC1: The Key Feature for Cancer Vaccine Success? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Docetaxel Alone or in Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial. [2022]