18 Participants Needed

Flu Vaccine for Breast Cancer

AL
Overseen ByAngela Limburg, RN, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial excludes patients who are currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents, so you would need to stop these medications to participate.

What data supports the effectiveness of the flu vaccine as a treatment for breast cancer?

The research does not provide direct evidence supporting the effectiveness of the flu vaccine for breast cancer. However, studies on other cancer vaccines, like those targeting HER2 or survivin proteins, show that vaccines can stimulate immune responses and potentially reduce cancer recurrence or slow tumor growth.12345

Is the flu vaccine generally safe for humans?

The flu vaccine, including versions like Fluzone Quadrivalent, has been studied for safety and is generally considered safe for humans. Some studies have noted that certain versions of the vaccine may cause more local reactions (like soreness at the injection site) and mild systemic reactions (like fever or fatigue) compared to non-adjuvanted vaccines, but these are typically not serious.678910

How is the Fluzone Quadrivalent vaccine unique in treating breast cancer?

The Fluzone Quadrivalent vaccine is unique because it is traditionally used as a flu vaccine, and its use in breast cancer is novel, potentially leveraging its immune-stimulating properties to help the body fight cancer, unlike standard breast cancer treatments that directly target cancer cells.1251112

What is the purpose of this trial?

This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.

Research Team

RR

Ruta Rao

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for women with triple-negative or HER2+ breast cancer who are about to start standard chemotherapy. They should be relatively active and able (ECOG 0-2) and have a confirmed diagnosis through tissue samples. The study excludes certain individuals, but the criteria aren't fully listed here.

Inclusion Criteria

My breast cancer is confirmed as either triple-negative or HER2 positive.
I am able to care for myself and perform daily activities.
I am set to receive recommended initial chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of seasonal flu vaccine directly into breast cancer tissue, with increasing doses across groups

3 months
Multiple visits for vaccine administration and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of dose-limiting toxicity

3 months post surgery

Treatment Details

Interventions

  • Fluzone Quadrivalent
Trial Overview The study tests injecting flu vaccine directly into breast cancer tumors before chemo starts. Participants will receive different doses of the vaccine in palpable or non-palpable tumors, administered by trained professionals using touch or ultrasound guidance.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Intratumoral influenza vaccineExperimental Treatment1 Intervention

Fluzone Quadrivalent is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Fluzone Quadrivalent for:
  • Prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Fluzone Quadrivalent for:
  • Prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Findings from Research

E75, an immunogenic peptide from the HER2 protein, has been shown to be safe and effective in stimulating an immune response in breast cancer patients when used as a vaccine with an immunoadjuvant.
In a study of 187 patients, those vaccinated with E75 + GM-CSF had a 5-year disease-free survival rate of 89.7%, significantly higher than the 80.2% in the control group, indicating a 48% reduction in the risk of cancer recurrence.
Clinical Development of the E75 Vaccine in Breast Cancer.Clifton, GT., Gall, V., Peoples, GE., et al.[2020]
The phase I clinical trial involving 10 patients with metastatic breast cancer demonstrated that the Her-2/neu multipeptide vaccine was safe and well-tolerated, with local erythema being the only reported side effect.
The vaccine successfully induced Her-2/neu-specific antibodies in 8 out of 10 patients, suggesting potential for clinical benefit similar to existing anti-Her-2 antibody therapies, while also reducing regulatory T cells that may suppress immune responses.
A virosomal formulated Her-2/neu multi-peptide vaccine induces Her-2/neu-specific immune responses in patients with metastatic breast cancer: a phase I study.Wiedermann, U., Wiltschke, C., Jasinska, J., et al.[2019]
The study demonstrated that a survivin peptide microparticle vaccine significantly slowed tumor growth in a triple negative breast cancer model using 4T1 tumor cells in mice, indicating its potential efficacy as an immunotherapy.
Vaccination led to a specific immune response, as evidenced by increased gamma interferon production in splenocytes, suggesting that targeting survivin could be a promising approach for treating triple negative breast cancer.
Survivin (BIRC5) Peptide Vaccine in the 4T1 Murine Mammary Tumor Model: A Potential Neoadjuvant T Cell Immunotherapy for Triple Negative Breast Cancer: A Preliminary Study.Burkholz, SR., Herst, CV., Carback, RT., et al.[2023]

References

Clinical Development of the E75 Vaccine in Breast Cancer. [2020]
A virosomal formulated Her-2/neu multi-peptide vaccine induces Her-2/neu-specific immune responses in patients with metastatic breast cancer: a phase I study. [2019]
Survivin (BIRC5) Peptide Vaccine in the 4T1 Murine Mammary Tumor Model: A Potential Neoadjuvant T Cell Immunotherapy for Triple Negative Breast Cancer: A Preliminary Study. [2023]
Neoadjuvant Chemotherapy and Immunotherapy in Luminal B-like Breast Cancer: Results of the Phase II GIADA Trial. [2023]
Melanoma vaccines: what we know so far. [2015]
Systematic review of the efficacy, effectiveness and safety of MF59® adjuvanted seasonal influenza vaccines for the prevention of laboratory-confirmed influenza in individuals ≥18 years of age. [2023]
[Cooperative phase II study of spansule tegafur (SF-SP)]. [2013]
Phase II trial of ICRF-187 in children with solid tumors and acute leukemia. [2019]
Treatment of previously treated metastatic breast cancer by mitoxantrone and 48-hour continuous infusion of high-dose 5-FU and leucovorin (MFL): low palliative benefit and high treatment-related toxicity. [2019]
Mitoxantrone, leucovorin and high-dose infusional 5-fluorouracil: an effective and well-tolerated regimen for the treatment of advanced breast cancer. [2019]
Recent advances in multivalent self adjuvanting glycolipopeptide vaccine strategies against breast cancer. [2021]
Synthesis and functional studies of self-adjuvanting multicomponent anti-HER2 cancer vaccines. [2022]
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