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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new treatment for invasive breast cancer with the HER-2/neu protein. The treatment uses a vaccine made from a participant's own blood cells (dendritic cell vaccine) to enhance the immune system's ability to fight cancer. Participants will receive varying doses of this vaccine alongside standard chemotherapy to determine the best approach. It suits individuals with stage II or III HER-2 positive breast cancer who can undergo specific chemotherapy treatments. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

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.

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

Research has shown that dendritic cell (DC) vaccines, such as the DC1 study vaccine, are generally safe for breast cancer patients. Previous studies found that these vaccines can enhance the immune system without causing serious side effects. One study demonstrated that when DC vaccines were combined with chemotherapy, they improved the function of the immune system's T cells (a type of white blood cell) and were well-tolerated.

Neoadjuvant chemotherapy, a common treatment for breast cancer administered before surgery to shrink tumors, sometimes requires dose adjustments or discontinuation due to side effects. Despite this, it remains a well-established and frequently used treatment option, indicating that its risks are known and manageable.

In summary, the DC1 vaccine appears safe based on previous research, and while neoadjuvant chemotherapy can have side effects, it is a standard practice in treating invasive breast cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Researchers are excited about the dendritic cell vaccine (DC1) for breast cancer because it offers a unique approach compared to the standard treatments like surgery, chemotherapy, and radiation. Most treatments work by directly attacking cancer cells, but DC1 harnesses the body's immune system to target and destroy cancer cells more naturally. The vaccine uses dendritic cells, which are key players in the immune response, to teach the immune system to recognize and fight breast cancer cells. This method could potentially lead to more personalized and effective treatment options with fewer side effects than conventional therapies.

What evidence suggests that the DC1 study vaccine could be an effective treatment for HER-2/neu positive invasive breast cancer?

Research has shown that dendritic cell vaccines, such as the DC1 study vaccine, may enhance the immune system's ability to combat HER2-positive breast cancer. These vaccines help the body identify and attack cancer cells by reversing tumor-induced immune suppression. In earlier studies, some patients experienced stable disease or partial tumor shrinkage after receiving similar vaccines, indicating potential benefits. In this trial, participants will receive DC1 vaccinations on different schedules to identify the optimal approach.

Neoadjuvant chemotherapy, another treatment option in this trial, is often used to shrink breast cancer tumors before surgery. It has proven effective in reducing the likelihood of cancer recurrence and improving survival rates. Together, these treatments aim to improve outcomes for patients with aggressive breast cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Haten Soliman, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12394260/

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. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223004730

Dendritic cell vaccines in breast cancer The results showed that autologous DCs combined with chemotherapy could restore T cell reactivity in BC patients and was safe, which makes DC a potential tumor ...

3. moffitt.org moffitt.org/newsroom/news-releases/moffitt-study-finds-vaccine-may-improve-breast-cancer-treatment-outcomes/

Moffitt Study Finds Vaccine May Improve Breast Cancer ... Dendritic cell vaccine shows potential to enhance chemotherapy effectiveness in HER2-postitive, ER-negative subtype.

4. 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10315441/

Efficacy of a Dual-Epitope Dendritic Cell Vaccine as Part of ... Forty-six percent of patients had stable disease after therapy, with 4% achieving a partial response and no complete responses. Immune responses were generated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8716407/

Phase I Clinical Trial of an Autologous Dendritic Cell ... The AdHER2 DC vaccine showed evidence of immunogenicity and preliminary clinical benefit in patients with HER2-expressing cancers, along with an ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02018458

Safety Study Of Chemotherapy Combined With Dendritic ... The primary objective of this study is to determine the safety and feasibility of combining cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.1086

Safety and initial clinical efficacy of a dendritic cell (DC) ... Safety and initial clinical efficacy of a dendritic cell (DC) vaccine in locally advanced, triple-negative breast cancer (TNBC) patients (pts).