Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Leukapheresis
- Dendritic Cell (DC) Vaccine
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov