Evaluating flu vaccine injections in breast cancer patients
A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer
This study is testing if giving two doses of the flu vaccine directly into breast cancer tumors can be safe and effective for women with specific types of breast cancer before they start chemotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06229392 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study aims to assess the safety and efficacy of administering two doses of a seasonal flu vaccine directly into breast cancer tumors. The study will involve women with triple-negative and HER2+ breast cancer, with vaccine administration performed by trained surgeons or radiologists. Participants will be grouped by increasing doses of the vaccine, and various biological samples will be collected for analysis. The active participation period begins one week prior to the start of standard neoadjuvant chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are women with histologically confirmed triple-negative or HER2+ invasive breast cancer who are planning to receive neoadjuvant chemotherapy.
Not a fit: Patients with uncontrolled illnesses, certain allergies, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the immune response against breast cancer by leveraging the flu vaccine.
How similar studies have performed: While this approach is novel, similar studies exploring intratumoral vaccine administration have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ECOG 0-2 * Patients must be planning to receive standard of car e neoadjuvant chemotherapy as defined by the most recent version of NCCN guidelines (www.nccn.org) * Patients must have histologically or cytologically confirmed invasive breast cancer that is either triple-negative or HER2+ (regardless of hormone receptor status) Exclusion Criteria: * Patients with any uncontrolled intercurrent illness. * Patients who have any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant * History of egg allergy * Patients currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the seasonal flu vaccine. * History of Guillain-Barré syndrome
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Ruta Rao, MD — Rush University Medical Center
- Study coordinator: Angela Limburg, RN, BSN
- Email: angela_d_limburg@rush.edu
- Phone: 312-942-3498
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.