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RecruitingEarly Phase 1

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

Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests a breast cancer vaccine made for each patient using gene data from their remaining tumor. It checks safety, whether the vaccine can be made and given, and how the immune system responds. It is for adults with high-risk breast cancer who still had a large amount of cancer left after chemotherapy given before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to understand and sign a study consent form.
  • Have stage II–III breast cancer with ER/PR levels of 10% or less and negative HER2 tests. Have had standard chemotherapy before surgery, with a large amount of cancer remaining (RCB II or III).
  • Have enough living tumor tissue from the breast or underarm lymph nodes on the same side available to Moffitt for gene testing.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have organs and bone marrow that work well enough for the study.
  • Have no signs of active cancer spread to distant body parts on scans. Join within 18 months of the last chemotherapy or radiation treatment meant to cure the cancer, whichever was later.
  • A past or current other cancer is allowed if it will not affect the study’s safety or results.
  • Women who could become pregnant must use birth control or avoid sex before joining and during the study. Tell the treating doctor right away about a pregnancy or possible pregnancy.

Who can't join

  • Have active cancer that has spread nearby and cannot be removed by surgery, or has spread to distant body parts.
  • Have a serious illness that is not controlled, or an autoimmune disease needing medicines that lower immune activity, that the study doctor finds unsafe for participation. Autoimmune disease means the immune system attacks the body.
  • Have a medical problem that makes pheresis unsafe, according to the doctor. Pheresis is a procedure that removes parts of the blood.
  • Are currently receiving another experimental treatment.
  • Have a mental health condition or life situation that would make it hard to follow study requirements.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

FL