Actively Recruiting
Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
16
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
CONDITIONS
Official Title
Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has stage II-III ER/PR less than or equal to 10% HER2 negative breast cancer treated with standard neoadjuvant chemotherapy and surgery with significant residual tumor (RCB II or III).
- Patient has sufficient residual primary breast tumor or ipsilateral breast axillary metastatic tissue accessible for whole exome sequencing.
- Patient is 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.
- Patients must have adequate organ and marrow function.
- Patients with prior or concurrent malignancy not interfering with study are eligible.
- Patients without active metastatic disease and within 18 months of last curative chemotherapy or radiotherapy dose.
- Women of child-bearing potential must agree to use adequate contraception during study participation.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Patients with active locally advanced unresectable or metastatic cancer.
- Patients with significant uncontrolled illness or autoimmune disease requiring systemic immunosuppressants deemed unsuitable by the investigator.
- Patients with medical issues making them unsuitable for leukapheresis.
- Patients currently receiving other investigational agents.
- Patients with psychiatric illness or social situations limiting study compliance.
- Pregnant women.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
N
Neveen Abdo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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