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Cancer Vaccine

Dendritic Cell Vaccine for Breast Cancer

Phase < 1
Recruiting
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has stage II-III ER/PR less than or equal to 10% HER2 negative by FISH and/or IHC breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to RCB II or III) disease.
Patient is 18 years of age or older.
Must not have
Patients with known active locally advanced unresectable or metastatic cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial will test a personalized breast cancer vaccine made from a patient's tumor data after chemotherapy to see if it is safe and effective.

Who is the study for?
This trial is for individuals with a high-risk type of breast cancer known as TNBC, who have already undergone initial chemotherapy. Participants should be those whose tumors still remain after this treatment and are willing to undergo further procedures to create a personalized vaccine.
What is being tested?
The study is testing the safety and immune response to a new breast cancer vaccine made from patients' own tumor information. It involves taking white blood cells through leukapheresis (a lab procedure) and using them to create the vaccine.
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms, fatigue, or allergic responses due to the personalized nature of the dendritic cell vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is at stage II-III, mostly not hormone-driven, HER2 negative, and still significant after initial treatment.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have enough accessible breast or nearby lymph node cancer tissue for genetic testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is advanced and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients enrolled who successfully undergo at least one vaccination.
Secondary outcome measures
Disease Free Survival (DFS)
Number of participants who achieve Immunogenicity after administration of vaccine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dendritic Cell (DC) VaccineExperimental Treatment2 Interventions
The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected. The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leukapheresis
2016
Completed Phase 2
~700

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,524 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
Hatem Soliman, MDStudy DirectorMoffitt Cancer Center
~11 spots leftby May 2029
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