Dendritic Cell Vaccine for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: TCH-P regimen

Must not be taking: Immunosuppressants

Disqualifiers: Inflammatory breast cancer, Uncontrolled illness, others

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

Compensation: Varies

Number of Visits: 3

31 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 cannot be on other investigational agents for breast cancer or require systemic immunosuppressant drugs.

What data supports the effectiveness of the dendritic cell vaccine treatment for breast cancer?

Research shows that dendritic cell vaccines can stimulate the immune system to target breast cancer cells, with some studies indicating reduced tumor markers and cancer cell presence after vaccination. Additionally, combining dendritic cell therapy with chemotherapy has shown promise in treating advanced breast cancer by enhancing immune response and potentially reducing tumor size. ^{1 2 3 4 5}

Is the dendritic cell vaccine for breast cancer safe for humans?

The dendritic cell vaccine for breast cancer has been shown to be safe in clinical trials, with patients tolerating the treatment well. It stimulates the immune system to target cancer cells without significant adverse effects. ^{1 2 6 7 8}

How is the dendritic cell vaccine treatment for breast cancer different from other treatments?

The dendritic cell vaccine for breast cancer is unique because it uses the body's immune system to target cancer cells by activating dendritic cells, which are special cells that help the immune system recognize and attack cancer. This approach is different from traditional chemotherapy, which directly targets and kills cancer cells, as it aims to enhance the body's natural immune response to fight the cancer. ^{1 2 9 10 11}

What is the purpose of this trial?

The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer. The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.

Research Team

Haten Soliman, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

This trial is for adults with stage II or III HER2+ invasive breast cancer, who are in good health otherwise, with normal organ and marrow function. They must not be pregnant or breastfeeding, have no severe illnesses that could affect study participation, and agree to use contraception. It's not for those with inflammatory breast cancer, uncontrolled diseases like heart failure or arrhythmias, immune deficiencies, certain allergies to vaccine components or chemotherapy drugs.

Inclusion Criteria

My doctor agrees I can have specific chemotherapy and follow-up care.

Patients must have normal organ and marrow function as defined below: leukocytes ≥3,000/μL, absolute neutrophil count ≥1,500/μL, platelets ≥100,000/μL, total bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal, creatinine within normal institutional limits - OR - creatinine clearance ≥60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, cardiac ejection fraction within institutional normal limits by either MUGA or ECHO at baseline, women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, ability to understand and the willingness to sign a written informed consent document

My breast cancer is at stage II or III, ERPR-negative, and HER2-positive.

Exclusion Criteria

I have an immune deficiency or take drugs to suppress my immune system.

I am not allergic to the study vaccine or similar chemotherapy drugs.

I have nerve damage that prevents me from receiving certain chemotherapy drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead In Phase

Participants receive DC1 study vaccinations with different schedules to determine optimal sequence

3 weeks

3-6 visits (in-person, depending on arm)

Expansion Phase

Participants receive DC1 vaccinations according to the optimal schedule and a booster at week 25, followed by surgery

25-28 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for recurrence-free survival and other outcomes post-surgery

Up to 3 years

Treatment Details

Interventions

• Curative Surgery
• DC1
• Neoadjuvant Chemotherapy

Trial Overview The trial tests a new type of treatment called DC1 dendritic cell vaccine alongside standard neoadjuvant chemotherapy (TCH-P regimen) before surgery. The DC1 vaccine is made from the patient's own blood cells and aims to boost the immune system to fight breast cancer more effectively.

Participant Groups

Group I: Expansion Phase Experimental Treatment 3 Interventions

DC1 vaccinations according to optimal vaccination schedule. Participants will receive a booster intranodal study vaccine at week 25 prior to receiving surgery. Participants will then undergo definitive curative surgery following completion of the neoadjuvant therapy, additional adjuvant locoregional/systemic therapy (as deemed appropriate by their treating physicians).

Group II: Lead In Phase - Arm A Active Control 3 Interventions

Arm A: One Dendritic Cell Vaccine (DC1) per week x 3 weeks.

Group III: Lead In Phase - Arm B Active Control 3 Interventions

Arm B: Two DC1 vaccinations per week (given 3 days apart i.e., Mon and Thurs or Tues and Friday) x 3 weeks.

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

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]

The HER2 peptide-pulsed DC1 vaccination was found to be safe and well-tolerated among 54 HER2-positive patients, with no significant differences in immune response rates across different injection methods (intralesional, intranodal, or both).

Patients with ductal carcinoma in situ (DCIS) showed a higher pathologic complete response (pCR) rate compared to those with early invasive breast cancer (IBC), suggesting that the immune response in sentinel lymph nodes may be a better indicator of treatment effectiveness than peripheral blood responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dendritic Cell Vaccination Enhances Immune Responses and Induces Regression of HER2pos DCIS Independent of Route: Results of Randomized Selection Design Trial. Lowenfeld, L., Mick, R., Datta, J., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Dendritic Cell Subpopulations Are Associated with Prognostic Characteristics of Breast Cancer after Neoadjuvant Chemotherapy-An Observational Study. [2023]

2. 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]

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

Effective combination of chemotherapy and dendritic cell administration for the treatment of advanced-stage experimental breast cancer. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Numerical and functional defects of blood dendritic cells in early- and late-stage breast cancer. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Dendritic cell-based therapeutics for breast cancer. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Trial watch: Dendritic cell-based anticancer immunotherapy. [2021]

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

Dendritic Cell Vaccination Enhances Immune Responses and Induces Regression of HER2pos DCIS Independent of Route: Results of Randomized Selection Design Trial. [2022]

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

Approaches to dendritic cell-based immunotherapy after peripheral blood stem cell transplantation. [2019]

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

A novel dendritic cell-based immunization approach for the induction of durable Th1-polarized anti-HER-2/neu responses in women with early breast cancer. [2022]

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

Immunotherapy in breast cancer: Current status and future directions. [2020]