Personalized vaccine for high-risk triple negative breast cancer after chemotherapy
Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy
This study is testing a personalized vaccine made from a patient's own immune cells to see if it can help people with high-risk triple negative breast cancer fight any leftover cancer after chemotherapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06435351 on ClinicalTrials.gov |
What this trial studies
This pilot protocol evaluates the safety, feasibility, and immunogenicity of a personalized dendritic cell vaccine for patients with high-risk triple negative breast cancer who have undergone neoadjuvant chemotherapy. The approach utilizes whole exome sequencing data from the patient's residual tumor to tailor the vaccine specifically to their cancer profile. The study involves leukapheresis to collect immune cells, which are then used to create the vaccine. The goal is to enhance the immune response against any remaining cancer cells post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage II-III triple negative breast cancer who have significant residual disease after neoadjuvant chemotherapy.
Not a fit: Patients with active metastatic disease or those whose prior malignancies could interfere with the study's assessments may not benefit from this trial.
Why it matters
Potential benefit: If successful, this personalized vaccine could improve outcomes for patients with high-risk triple negative breast cancer by enhancing their immune response to residual cancer cells.
How similar studies have performed: While personalized cancer vaccines are an emerging field, this specific approach utilizing whole exome sequencing in triple negative breast cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Neveen Abdo
- Email: neveen.abdo@moffitt.org
- Phone: 813-745-4412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.