Flu Vaccine for Breast Cancer
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 2 doses of seasonal flu vaccine directly into breast cancer tissue, with increasing doses across groups
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of dose-limiting toxicity
Treatment Details
Interventions
- Fluzone Quadrivalent
Fluzone Quadrivalent is already approved in United States, European Union for the following indications:
- Prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine
- 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