24 Participants Needed

Dendritic Cell Vaccine for Breast Cancer

(DecipHER Trial)

AC
RC
Brian J. Czerniecki, M.D., Ph.D. profile photo
Overseen ByBrian J. Czerniecki, M.D., Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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, but you cannot be on other investigational drugs or active cancer treatments. It's best to discuss your current medications with the trial team to see if they are allowed.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or active cancer treatments, and you should not be using long-term corticosteroids or have received a live vaccine within 30 days before joining the trial.

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

Research shows that dendritic cell vaccines targeting HER2 can generate immune responses that delay tumor growth and improve survival in preclinical models of HER2-positive breast cancer. Additionally, small studies in patients with high-risk breast cancer or metastatic cancers expressing HER2 have shown that these vaccines are safe and can induce modest immune responses, suggesting potential benefits in preventing recurrence and enhancing antitumor immunity.12345

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

Research shows that dendritic cell vaccines targeting HER2 can generate immune responses that delay tumor growth and improve survival in preclinical models of HER2-positive breast cancer. Additionally, small studies in patients with high-risk breast cancer have shown that these vaccines are safe and can induce modest immune responses, suggesting potential benefits in preventing recurrence.12345

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

Research shows that the dendritic cell vaccine targeting HER2 in breast cancer patients is generally safe, with no toxicities reported in small studies. Patients did not experience harmful side effects from the vaccine.12567

Is the Dendritic Cell Vaccine for Breast Cancer safe for humans?

Research shows that the Dendritic Cell Vaccine targeting HER2 in breast cancer patients has been tested in small studies and found to be safe, with no toxicities reported in patients. This suggests that the vaccine is generally safe for human use.12567

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 own immune cells, called dendritic cells, to target and attack cancer cells by priming them with specific proteins (HER2 and HER3) found on cancer cells. This approach aims to stimulate a targeted immune response, potentially offering a new way to treat cancers that overexpress these proteins, unlike traditional therapies that may not specifically target these antigens.12789

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 own immune cells, called dendritic cells, to target and attack cancer cells that overexpress the HER2 or HER3 proteins. This approach aims to stimulate a specific immune response against the cancer, potentially offering a more targeted and personalized treatment compared to traditional therapies.12578

What is the purpose of this trial?

The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.

Research Team

Ricardo Costa | Moffitt

Ricardo Costa, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for adults over 18 with early-stage Triple Negative or HR low positive breast cancer, who can undergo standard chemotherapy and surgery. Participants need normal organ/marrow function, no severe autoimmune diseases, not pregnant/nursing, and no recent vaccines or other cancer treatments.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent agreement prior to study registration
Patients must have normal organ and marrow function within 14 days of registration: ANC ≥ 1500/μL, Platelets ≥ 75 000/μL, Total bilirubin ≤ 1.5 x institutional ULN (except patients with Gilbert's syndrome), AST/ALT ≤ 3 x institutional ULN, Creatinine ≤ 1.5 x institutional ULN, Left ventricular ejection fraction above institutional lower limit of normal
My tumor is either not hormone receptor positive or has low hormone receptor positivity.
See 5 more

Exclusion Criteria

I have no cancer history except for certain skin cancers, cervical cancer in situ, or any cancer I've been free from for 3+ years.
I have not received a live vaccine in the last 30 days.
I have been treated with a therapy targeting HER2 or HER3 before.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3-primed DC1 study vaccines

4 weeks
Multiple visits for dose escalation and monitoring

Treatment

Participants receive DC1 injections and standard of care chemotherapy

24 weeks
Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Treatment Details

Interventions

  • HER2-primed Dendritic cells
  • HER3-primed Dendritic cells
Trial Overview The DecipHER Trial tests if a new vaccine made from Dendritic cells (immune cells) primed against HER3/HER2 proteins can boost the effectiveness of standard chemo in treating certain breast cancers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dendritic Cell Vaccine dose EscalationExperimental Treatment2 Interventions
Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

The Shulas' Foundation

Collaborator

Trials
1
Recruited
20+

Findings from Research

In a preclinical model of HER2+ breast cancer, vaccination with class II HER2-pulsed dendritic cells (DC1) led to increased infiltration of both CD4 and CD8 T cells in tumors, resulting in delayed tumor growth and improved survival.
Combining class II HER2-DC1 with anti-PD-1 therapy significantly enhanced anti-tumor efficacy, suggesting that this combination could be a promising treatment strategy for patients with metastatic HER2 breast cancer.
Sequential Anti-PD1 Therapy Following Dendritic Cell Vaccination Improves Survival in a HER2 Mammary Carcinoma Model and Identifies a Critical Role for CD4 T Cells in Mediating the Response.Kodumudi, KN., Ramamoorthi, G., Snyder, C., et al.[2023]
Immunizations using dendritic cells (DCs) loaded with HER2 tumor antigens were found to be safe, with no toxicities reported in patients with high-risk breast cancer or metastatic cancers expressing HER2.
In a pilot study, patients receiving DCs loaded with the HER2 intracellular domain showed promising results, with all three patients having no recurrence of cancer for up to 2.5 years, indicating potential efficacy in preventing cancer recurrence.
HER2 dendritic cell vaccines.Morse, MA., Clay, TM., Colling, K., et al.[2019]
Intratumoral delivery of HER2-pulsed dendritic cells combined with anti-HER2 antibodies led to complete tumor regression in 75-80% of treated mice, significantly enhancing immune cell infiltration compared to subcutaneous delivery and standard chemotherapy.
This approach not only induced strong anti-HER2 immune responses but also provided lasting immunity that prevented secondary tumor formation, suggesting it could be a promising alternative to traditional chemotherapy for HER2 positive breast cancer.
Intratumoral delivery of dendritic cells plus anti-HER2 therapy triggers both robust systemic antitumor immunity and complete regression in HER2 mammary carcinoma.Ramamoorthi, G., Kodumudi, K., Snyder, C., et al.[2022]

References

Sequential Anti-PD1 Therapy Following Dendritic Cell Vaccination Improves Survival in a HER2 Mammary Carcinoma Model and Identifies a Critical Role for CD4 T Cells in Mediating the Response. [2023]
HER2 dendritic cell vaccines. [2019]
Intratumoral delivery of dendritic cells plus anti-HER2 therapy triggers both robust systemic antitumor immunity and complete regression in HER2 mammary carcinoma. [2022]
HER2-specific T lymphocytes kill both trastuzumab-resistant and trastuzumab-sensitive breast cell lines in vitro. [2021]
Development of vaccines for high-risk ductal carcinoma in situ of the breast. [2021]
The clinical development of vaccines for HER2+ breast cancer: Current landscape and future perspectives. [2017]
Targeting of the non-mutated tumor antigen HER2/neu to mature dendritic cells induces an integrated immune response that protects against breast cancer in mice. [2021]
Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. [2021]
Identification of Immunogenic MHC Class II Human HER3 Peptides that Mediate Anti-HER3 CD4+ Th1 Responses and Potential Use as a Cancer Vaccine. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security