Personalized vaccine for high-risk triple negative breast cancer after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Neveen Abdo
• Email: neveen.abdo@moffitt.org
• Phone: 813-745-4412

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Extended-interval versus standard-interval immunotherapy for advanced triple-negative breast cancer

  This trial tests whether giving immunotherapy less often works as well and causes fewer immune-related side effects than the standard schedule for adults with advanced triple-negative breast cancer who responded to initial combination therapy.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07401537

• Adaptive biomarker-driven therapies for metastatic breast cancer

  This trial tests whether matching targeted drug combinations to tumor biomarkers helps people with ER+/HER2- or triple-negative metastatic breast cancer who are starting second-line treatment.

  Recruiting at 4 sites Phase 2 UNC Lineberger Comprehensive Cancer Center · New Haven, Connecticut and 5 other locations · NCT07340541

• Serial multisite image-guided biopsies to track breast cancer evolution

  The team will try taking repeated image-guided biopsies and blood samples from adults with metastatic or advanced breast cancer to see how their tumors change during treatment.

  Recruiting Royal Marsden NHS Foundation Trust · London · NCT07084571

• Using mistletoe extract with pembrolizumab for treating triple negative breast cancer

  This study is testing if adding mistletoe extract to pembrolizumab can help adults with triple negative breast cancer feel better after surgery.

  Recruiting Phase 4 Ilsan Cha hospital · Goyang-si, Gyeonggi-do · NCT06920810

• Understanding breast cancer response during pre-surgery treatment

  This study is trying to see how breast cancer responds to treatment before surgery by looking at tissue and blood samples from patients to find out what factors might affect their recovery and risk of cancer coming back.

  Recruiting Royal Marsden NHS Foundation Trust · London · NCT06681064

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.