Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of treatment for patients with high-risk triple-negative breast cancer (TNBC) who have already received standard chemotherapy and surgery. The study is testing a personalized vaccine made from the patient's own tumor cells to see if it is safe and if it helps the immune system fight any remaining cancer cells. Participants will need to provide a sample of their tumor tissue for analysis, which will help create this tailored vaccine.

To be eligible for the trial, patients must be 18 years or older and have specific types of breast cancer that have not spread to distant parts of the body. They should have significant residual tumor tissue after treatment with chemotherapy and surgery. Those with certain health conditions or who are currently receiving other experimental treatments may not qualify. If you participate, you can expect to receive close monitoring and care throughout the study. It's important to note that women who could become pregnant will need to use contraception during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.
• • Patient is 18 years of age or older.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• • Patients must have adequate organ and marrow function.
• • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• • Patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment.
• • Women of child-bearing potential 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. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• • Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • Patients with known active locally advanced unresectable or metastatic cancer.
• • Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).
• • Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.
• • Patients who are currently receiving any other investigational agents.
• • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
• • Pregnant women are excluded from this study.

Trial Officials